Article 35 of the Organic Law 1/1990 of 3 October, for the General Management of the Educational System, provides that the Government, after consulting the Autonomous Communities, will establish the titles corresponding to the vocational training, as well as the minimum teaching of each of them.

Once, by Royal Decree 676/1993 of 7 May, the general guidelines for the establishment of vocational training qualifications and their corresponding minimum teachings have been laid down, the Government should also After consulting the Autonomous Communities, as provided for in the abovementioned rules, establish each professional training title, set out their respective minimum teachings and determine the various aspects of the relevant academic organisation. to professional lessons which, without prejudice to the powers conferred on them Educational administrations responsible for the establishment of the curriculum of these teachings, guarantee a basic training common to all students.

For these purposes, the duration and level of the corresponding training cycle should be determined in each case; the convalidations of these teachings and the access to other studies; the minimum requirements of the centers that provide the relevant teaching; the specialties of the teaching staff to be taught, as well as, where appropriate, in agreement with the Autonomous Communities, the equivalence of qualifications for teaching purposes as provided for in the additional provision Eleventh of the Organic Law of 3 October 1990 on the General Management of the System Educational.

On the other hand, and in compliance with article 7 of the aforementioned Royal Decree 676/1993, of 7 May, it is included in this Royal Decree, in terms of professional profile, the expression of the professional competence characteristic of the title.

This Royal Decree establishes and regulates in the basic aspects and elements above mentioned the title of superior Technician in the manufacture of pharmaceutical and related products.

In its virtue, on the proposal of the Minister of Education and Science, consulted by the Autonomous Communities and, where appropriate, in agreement with them, with the reports of the General Council of Vocational Training and the School Council of the State, and after the Council of Ministers had been deliberating at its meeting on 28 May 1993.

DISPONGO:

Article 1.

The title of the superior Technician is established in the manufacture of pharmaceutical and related products, which will be of official character and validity throughout the national territory, and the corresponding minimum teachings are approved in the Annex to this Royal Decree.

Article 2.

The duration and level of the corresponding training cycle, the specialties of the teacher who must teach the teaching of the training cycle, as well as the equivalence of qualifications for teaching purposes, the requirements the minimum of the centres that provide this training cycle, and the convalidations of these teachings and the access to other studies are those set out in the same annex.

Final disposition first.

This Royal Decree, which is of a basic nature, is given in the use of the powers conferred on the State in Article 149.1.30. of the Constitution, as well as in the additional provision first, paragraph 2 of the Organic Law The Law of 3 July 1985 on the Right to Education, and by virtue of the empowerment conferred on the Government by Article 4.2 of the Organic Law 1/1990 of 3 October of General Ordination of the Educational System.

Final disposition second.

It is for the Minister of Education and Science and the competent bodies of the Autonomous Communities to lay down, in the field of their powers, how many provisions are necessary for the implementation and development of the provisions of the Royal Decree.

Final disposition third.

This Royal Decree will enter into force on the day following its publication in the Official Journal of the State.

Given in Madrid to May 28, 1993.

JOHN CARLOS R.

The Minister of Education and Science,

ALFREDO PEREZ RUBALCABA

ANNEX

INDEX

1. Title identification:

1.1 Naming

1.2 Level

1.3 Training Cycle Duration

2. Production system reference:

2.1 Professional profile:

2.1.1 General Competition

2.1.2 Professional capabilities

2.1.3 Responsibility and autonomy

2.1.4 Competition Units

2.1.5 Professional Realizations and Domains

2.2 Evolution of professional competence:

2.2.1 Changes in technological, organizational and economic factors

2.2.2 Changes in professional activities

2.2.3 Changes in training

2.3 Position in the production process:

2.3.1 Professional and work environment

2.3.2 Functional and technological environment

3. Minimum teachings:

3.1 General objectives of the training cycle

3.2 Professional modules associated with a Competition Unit:

-Organization and management in process industries

-Pharmaceutical plant services and areas

-Pharmaceutical process

-Quality control in the pharmaceutical industry

-Chemical safety and environment

3.3 Cross-sectional professional module: relationships in the workbench

3.4 Professional work-center training module

3.5 Professional training and guidance module

3.6 Baccalaureate materials that have been due to be cured to access the training cycle corresponding to this title

4. Teachers:

4.1 Teacher Specialties to be taught by professional modules in the training cycle

4.2 Materies and/or areas that may be imparted by the specialties of the faculty defined in this Royal Decree

4.3 Qualifications of qualifications for teaching purposes

5. Minimum requirements for teaching these lessons:

5.1 Minimum space and facilities requirements

6. Convalidations, correspondences and access to higher education:

6.1 Professional modules that can be subject to validation with occupational vocational training

6.2 Professional modules that can be matched with work practice

6.3 Access to University Studies

1. Title identification

1.1 Denomination: manufacture of pharmaceutical and related products

1.2 Level: Higher-grade vocational training

1.3 Training Cycle Duration: 1,400 Hours

2. Reference to the production system

2.1 Professional profile

2.1.1 General Competition

Organize and participate in a production line or equipment, controlling the pharmaceutical process and its quality level, complying with the correct manufacturing standards, and monitoring compliance with safety standards and environmental.

2.1.2 Professional capabilities

Organize and direct the work of other lower-skill level technicians.

Interpret production plans and specify them in written instructions to manufacture, under the direction of an authorized person, various batches of pharmaceutical and related products.

Possess a comprehensive and integrated vision of pharmaceutical processes, understanding the function of the various facilities and equipment to achieve the objectives of production and technical, organizational, economic and of his work in the process.

Adapt to the technological, organizational, economic and labor changes that have an impact on your professional activity and the production system of the pharmaceutical industry.

Apply your own work techniques to optimize the production of a set of lots according to criteria of efficiency, economy and productivity, taking into account the conditions of the area, the quality and safety standards, and minimizing errors that result in complementary treatments and time losses.

Define and monitor the operations of the product batch manufacturing process, in areas with diverse environmental specifications, identifying the procedures and standards, checking the values of the process variables where necessary, monitoring the specified controls of the raw materials and conditioning materials, the control graphs and resolving incidents or anomalies in the work and reporting them.

Maintain fluid relationships with the members of the functional group in which it is integrated responsible for achieving the objectives assigned to the group, respecting the work of others, organizing and directing tasks The European Union is a major partner in the development of the European Union, and the European Union is a major partner in the European Union.

Communicate verbally or in writing with the engineering and quality departments to cure requests for repair of the means of production and control, and to request checks, analyses and exit authorizations final products.

Solve problems and make decisions about their actions or those of others, identifying and following established rules, within the scope of their competence, and consulting those decisions when their impact economic or security are important.

Discern from unforeseen situations, those in which you should consult and address the right person and, likewise, those in which you must respect the autonomy of your subordinates.

2.1.3 Responsibility and autonomy

This professional receives the instructions primarily through the batch manufacturing guide and has to identify and distribute the relevant operating rules and procedures.

In case of emergency, when the situation created cannot be resolved by predefined instructions, the responsibility of this technician will be limited to transmit the event to its hierarchical superior.

This technician is self-contained in the following general functions or activities:

Machines and installations: verification of operation and adjustment to standards. Breakdown ratio for maintenance. Complex format change on machines. Proposal for improvements and amendments.

Raw materials and products: organization of the distribution and flow of materials. Quality tests in process.

You can be assisted in:

Machines and facilities: preventive and corrective maintenance. Installation and adjustment of equipment, measuring and control instruments.

Raw materials and products: bacteriological and biological control of sterilization agents. Complex analysis of materials or products.

Must be assisted in:

Machines and installations: installation and adjustment of new equipment. Corrective maintenance.

Raw materials and products: quality, safety and environmental protection specifications.

2.1.4 Competition Units

1. Organize the manufacture of pharmaceutical and related products.

2. Verify the compliance of the equipment and process conditions with the established standards and specifications.

3. Coordinate and control the manufacture of pharmaceutical and related products. 4. Ensure the quality of pharmaceutical and related products in the process.

5. Comply with and enforce the correct manufacturing, safety and environmental standards of chemical-pharmaceutical process.

2.1.5 Professional Realizations and Domains

Competition Unit 1: Organize the manufacture of pharmaceutical and related products

REALIZATION CRITERIA

1.1 Define, or participate in the definition of process information that ensures the feasibility of production, optimizing the available resources. /From the production plans:

The necessary operations to perform in production or control have been set.

The sequence in which the operations set as required must be performed.

The machines or jobs that must be involved in each operation have been defined.

The appropriate personnel have been determined for each operation.

Required materials have been referenced in the process of each operation.

The useful and useful auxiliary elements have been set.

Time has been allocated for each operation.

1.2 Establish the production and flow of materials program according to the analysis of the programmed campaigns or batches, the characteristics of the flow of materials and the load of the production unit. /The beginning and termination times of each operation have been defined.

The times when the required materials are ready to be prepared and the necessary movements from the warehouse until the finished product is out.

The times when the auxiliary elements are going to be needed are defined.

The specific machines or jobs to be involved in each operation have been established.

The workers in each category who must intervene in each operation have been specified.

1.3 Apply the correct manufacturing rules in your organization and programming work.

The knowledge of the correct manufacturing standards (GMP) has been applied in the elaboration of the standard operating procedures (SOPs), on reception, handling, sampling, storage, identification, etc.

1.4 Collect data, perform calculations and write a technical production or control report. /The report has responded to the objective and contains data, results, conclusions, tables and the report's recipients.

Calculations have been performed on equipment and processes in terms of matter and energy balance, heat transmission, cost assessment and performance calculation.

The appropriate terminology has been used and the data has been offered with accuracy and accuracy.

The scientific-technical report has been drafted in a concise manner and according to the drafting conventions to account to its superiors in the course of the operations and the results obtained.

The data has been compiled to provide a clear presentation of the parameters.

The charts and charts, histograms, tables, or tables required in the report have been performed.

The data and results obtained with reference books and technical information of measurement or test analysis have been compared.

The results have been prepared to be processed by computer media.

The technical report has been delivered within the appropriate time frame and has responded to the needs of the superior or the applicant.

1.5 Classify, update, and distribute the technical documentation, for use in the production unit or for technical support for sales. /The documentation of the records has been archived and preserved in full during the established time and has allowed to reconstruct the tracking of a particular lot.

All usage documents have been updated and the previous ones have been removed.

Useful technical documentation has been selected for sale and, if necessary, transmitted to customers.

Technical documents have been classified and coded, according to the established policy estimating the most or least confidential.

Professional Domain

a) Means of production: computer equipment. Simulators and training equipment. Audiovisual media and information panels. Files.

b) Materials and intermediate products: production plans. Consignment documentation to be classified or used: production records, test and analysis records, standards manuals, technical manuals, chemical and laboratory material catalogues, journals and specialised newspapers, research and technological development reports.

c) Products or results of the work: technical information with technical specifications of products, working standards or established methods, time rates, lists of materials, standard operating procedures. Classified, updated and in-use documentation. Technical reports.

d) Processes, methods and procedures: manufacturing process of pharmaceutical and related products, methods of production programming, methods of reporting, methods of classification of documentation.

e) Information: production process diagram, company organization chart, production schedule, procedure and operating instructions. Rules arising from the collective agreement and other regulations. Documentation of products and machines.

f) Personal and/or target organisations: production department, sales department, staff in charge.

Competition Unit 2: Verify compliance of process equipment and conditions with established standards and specifications

REALIZATION CRITERIA

2.1 Participate in the installation and ensure the adjustment and implementation of the instruments and equipment of production or control. /The section of the manual of instructions concerning the assembly or installation of the apparatus or instrument in question has been read and interpreted.

The plans, diagrams and diagrams have been read and interpreted, which deal with the disposal of parts and equipment, and the people involved in the installation and equipment project have been informed.

The conditions of installation according to the type of work to be performed, location of the workplace, persons involved in the installation, verification of the availability of the equipment, apparatus, elements, elements, tools and instruments and stages of the performance of the work.

Functional criteria of reliability (electrical and mechanical), maintenance facility, accessibility of controls and adjustments, safety, environmental conditions, identification, noise and vibration and variation of the temperature.

Installation operations have been monitored, verifying the good status of the material to be installed, the application of the recommendations made to the installer, and the quality of the installer's work.

Verification has been performed on the installation of the equipment as to:

-Quality of the assembly of the mechanical, electrical and mobile elements.

-Quality of operation by means of previous tests.

-Calibration and adjustment of control instruments, systems and processes.

-Construction according to safety standards and requirements.

2.2 Monitor the good status and operation of process teams. /The production, purification or testing equipment has been verified by means of visual, tactile or auditory observation methods, obtaining certain values by direct measurement or by indirect measurement, verifying the equipment at rest, in a vacuum and in operation loaded.

To obtain the desired performance, the adjustments to be made on the different production equipment have been determined.

2.3 Ensure the cleaning and maintenance of equipment use and, where appropriate, request external maintenance. /It has been proven that the required degree of cleanliness is achieved in the production operations.

In a new campaign, the dismantling, assembly and cleaning of the equipment has been carried out to avoid cross-contamination.

In change of format you have participated when the complexity or risk of the job requires it.

There have been signs of deterioration, wear or malfunction of equipment, have been recorded and have been transmitted to the maintenance officer when it has not been possible to be solved by his or her work team.

2.4 Propose improvements and modifications to be made to the production equipment to achieve the fixed performance. /There have been proposed improvements in the positioning of the machines in order to facilitate the transport/materials in the process, or to avoid stages of the same.

Changes have been proposed in the machines to more simply make the change of format or the cleaning of the machine.

The application of automatic systems has been proposed to facilitate the process and avoid manual work, reducing possible human errors by repetitive manipulation.

It has been achieved, through improvements and modifications, optimization of the process by reduction of time, improvement of the method and increase of the yield.

The suggested modifications have been communicated in time and form to the production manager.

2.5 Verify the operation of ancillary services that provide the necessary conditions for the process. /The regulation of the factors of temperature, humidity, etc., specific for each manufacturing area according to the function to be performed or the product to be obtained.

It has been controlled that air cleaning systems have worked and have met the conditions of clean areas for the manufacture of sterile products.

Any failure occurred to reset the processing conditions.

Professional Domain

a) Means of production: useful and tools for use maintenance. Air cleaning systems. Detection devices and measurement of environmental values (thermometer, hygrometer, etc.). Useful and standard cleaning products.

b) Materials and intermediate products: mechanical and electrical elements for installation and/or maintenance.

c) Work products or results: installed equipment. Equipment in correct operation. Area under process conditions.

d) Processes, methods and procedures: installation methods and techniques. Equipment verification methods. Procedure for recording environmental conditions. Written methods of cleaning and disinfection.

e) Information: Equipment manual. Maintenance manual. Normalized and referenced cleaning tab. Diagrams, drawings and equipment schemes. Theoretical and statistical studies of equipment optimization for process improvement. Optimization reports.

f) Personal and/or target organisations: personnel and production managers. Process engineering. Department of maintenance.

Competition Unit 3: Coordinate and control the manufacture of pharmaceutical and related products

REALIZATION CRITERIA

3.1 Interpreting and applying the appropriate process control and operating procedures/instructions, to obtain the specified products with the required quality and quantity.

The instructions to the production plans with determination of the products to be manufactured, regime and conditions of the equipment, and time of realization have been appropriate.

The required quantities of active and inactive materials have been calculated from the manufacturing order. The requirements regarding the available inventories have been verified and have been directed to the manufacturing sites.

3.2 Inform and continuously inform and train staff in their capacity according to work needs. /It has been collaborated in the definition of the training needs of the staff in charge, in the case of the implementation of new equipment, instruments or processes.

There has been an active participation in the practical training of new incorporation staff.

A permanent attitude has been maintained, during the execution of the job, of helping to improve the training and the acquisition of experience of the staff in charge.

There has been a participation in theoretical training actions of personnel.

The understanding of the correct manufacturing standards in the operations to be performed has been verified by the personnel.

3.3 Distribute and coordinate resources in your production unit. /The documents needed for the work have been delivered (work procedures, time fees, list of materials, road maps, material vouchers, etc.).

The flow of materials has been controlled so that it can be found in the precise locations correctly identified, weighed or heavy.

The saturation of each position or means of production has been studied by coordinating their actions to avoid interference.

The instructions have been found to have been understood and clarified if necessary, checking that they are put into practice.

3.4 Order the launch of the job in your production unit. /The daily work has been distributed and, if necessary, the staff has been technically instructed.

The cleanup and order of the area of your production unit has been secured.

It has been proven that everything needed for each operation is in order and disposition of use.

The beginning of each operation has been ordered in the expected times.

It has been taken care that the flow of material circulation does not stop or delay in its unit and that the materials from storage correspond in weight, proportions according to formula, homogeneity, etc.

Auxiliary services have been controlled to provide the necessary conditions for the operation (water, vacuum, positive pressure, air cleaning).

3.5 Control the line/and/or production phase of pharmaceutical and related products. /We have participated with the staff in their position in the complex set-up, in the monitoring of instruments from the control panel and in the regulation of control ties.

Possible deviations have been obtained with respect to the forecasts of the work schedule and have been reported to its superior.

Measures have been proposed to correct or improve production in your unit.

Successful action in clean areas or areas of risk has been proven.

The work area has been kept free of products or elements outside the process at all times.

Actions have been decided in case of emergency, in order to restore the operating conditions.

The production phases (elaboration of shapes, dosage and conditioning) have been coordinated to achieve the optimal flow of materials.

3.6 Report on output results. /The report has included periods of rest, work and waiting for staff.

The stop and use periods for the machines have been recorded.

The product obtained qualitatively and quantitatively has been recorded as well as the calculations made to determine the quantities of raw materials needed in the manufacture.

The physical aspect and ongoing reactions of raw material manufacturing have been reported.

3.7 Meet the manufacturing tab for tracking the manufactured batch. /The completed manufacturing tab contains:

-Dates (for the writing of the sheet, for mixing ingredients, for quality control in the manufacturing process, for the purpose of manufacture).

-Build appliances used (number, name, last cleanup date).

-Batch number (n. lot of raw materials, n. of batch of samples, n. of a batch of manufactured product).

-Firmas (of the manufacturing stages, signatures gathered in heavy and in mixture of each ingredient, signatures in the various stages of quality control, conditioning firms).

-Quantities (n. of units in manufacture, mass of ingredients, total mass in manufacture, n. samples, mass of samples).

-In-flight controls (controls of measures carried out, quality control of the physical and chemical properties of manufactured products, equipment and machinery operating graphs).

-Performance in the course of manufacturing (theoretical, real performance, performance in critical stages of manufacturing).

-Adjustment and control of apparatus (verification of the apparatus used, adjustment depending on the product to be manufactured).

Professional Domain

a) Means of production: production unit equipment: size reducers (sprayers, micronizers, mills). Separators (sieves). Filters. Extractors. Desiccators. Atomizers. Lyophilizers. Mixers, agitators. Teams of suspensions and emulsions. Aerosol equipment. Distillers. Encapsulators, compressors, granulators. Graggy pumps. Injection preparation equipment. Equipment for the preparation of suppositories and eggs. Ophthalmic preparation equipment. Preparation kits of creams and ointments. Instruments associated with equipment for measurement of variables (temperature, pressure, flow, etc.). Regulators of the variables, included in equipment. Equipment for the production of specific tests in production. Instrument and container for sampling. Packaging lines with: dispensers, fillers, packers (of powder, solids, liquids), electronic counter, labelling. Measurement instruments of dimensions of conditioning elements, and of process variables. Regulators of volume, speed, filling time, temperature, etc. Test instruments. Instrument of sampling. Control systems per panel or distributed. Computer equipment.

(b) Materials and intermediate products: basic pharmaceutical products, excipient and adjuvant. Powders and granules. Mixtures and solutions. Prepared forms, powders, solutions, propellant gases. Packaging material (glass and plastic containers, envelopes, leaflets, labels, seals, boxes, etc.).

c) Products or results of the work: solid, semi-solid and fluid products. Tablets, grasses, capsules, injectables, suppositories and eggs, creams and ointments, oral solutions, ophthalmic preparations, aerosols. Pharmaceutical forms and related products dosed, filled and conditioned. Completed manufacturing fiche. Manufacturing instructions.

d) Processes, methods and procedures: Discontinuous processes of elaboration and conditioning of forms. Methods of making pharmaceutical forms and related products. Special sampling procedures and critical testing procedures. Safety standards. Manufacturing and conditioning guide. Safety and personal hygiene standards in the packaging. Procedures for recording and reporting. Material flow logistics.

e) Information: written instruction sheets issued to the staff on operation, test and sampling. Written report of production results and incidents. Verbal communication when necessary. Complete documentation of the batch and the conditioning material used. Charts or control letters. Bulletins of movement of materials. Completed manufacturing fiche.

f) Personal and/or target organisations: dosing line, filling and packaging. Quality control department. Warehouse. Responsible for the production department.

Competition Unit 4: Ensuring the quality of pharmaceutical and related products in the process

REALIZATION CRITERIA

4.1 Interpret the quality plan and control its compliance.

All elements of the company's quality system and rules that affect your area of responsibility have been identified.

You have identified your interventions in the different phases of the quality control process:

-Quality of suppliers.

-Receiving.

-Process quality.

-Product quality.

4.2 Organize the storage, classification and distribution of materials to the productive areas. /All reception, storage and expedition documents have been checked and registered.

The computer registry or other methods of the materials that have been received and dispatched have allowed stock control.

The warehouse has been distributed to avoid risks and ensure quality, following criteria of rationality and logistics.

All material has been labeled and distributed to avoid confusion.

The classification has been performed under the correct manufacturing standards and has allowed the quick and efficient search of each material.

The heavy materials have been carried out in the heavy area under written procedures.

The distribution of materials has been organized so that each type and quantity of matter or container has been distributed according to the manufacturing needs and all the distributed material has been unequivocally identified. and safe so that you do not suffer any contamination or deterioration.

All the received materials have been checked to verify their compliance with the requirements and the samples or tests prescribed for quality have been prepared.

4.3 Distribute and coordinate quality control work in the process of your production unit. /Documents (procedures and instructions) have been delivered for online control charts according to production schedule.

It has been proven that everything required for the online control operation is in order and disposition of use.

4.4 Review online control charts. /It has been controlled that the intermediate product samplings have been performed according to the production schedule.

Special or extraordinary samples have been taken if necessary.

Knowledge about the stability of a pharmaceutical form and the phenomena that may influence the stability of preparations have been taken into account.

Quality control moments have been arranged in the critical stages of manufacturing (premix of ingredients, mixture, before conditioning, after conditioning).

Online controls have been checked, by visual verification or by applying the procedure described and recording them in the control charts.

4.5 Control of the quality of raw materials, semi-finished materials, packaging elements and finished products for approval by the authorised person, pharmaceutical and related products. /A visual verification of the raw materials, conditioning elements and products has been carried out.

The prescribed mechanical tests have been performed.

The percentage of the various ingredients in a finished product has been calculated by measuring the amount of each of the active ingredients in the pharmaceutical product.

The various reference books useful for the investigation of the numerical value of the various physical or chemical constants have been identified.

The numeric value of physical or chemical factors has been calculated.

The results have been presented consistently.

The results obtained with the standards established by quality control have been compared.

The results have been approved by the authorized person to validate the control.

4.6 Propose corrective measures against quality deviations. /Critical defect bulletins have been completed, analyzing the possible causes of these anomalies.

Correction measures have been proposed, or more data has been requested, to correct the defect.

Correction measures have been implemented when authorized.

4.7 Get results of the quality work in process and report them. /We have obtained data from the times invested in the work of quality control in previewed processes.

The detected failures or failures have been recorded.

The achieved returns have been calculated.

The quality data bank has been handled and the batch documentation has been reviewed.

Results have been reported through written or verbal reports as required.

Professional Domain

a) Means of production: system of transport of materials. Storage systems. Warehouse control computer equipment. Instruments and apparatus for determining chemical properties: melting point apparatus, boiling point apparatus, colorimeter, apparatus for burst point, ultraviolet, infrared. Instrumental takes samples. Instruments and apparatus for physical testing: brightness, humidity, viscosity, hardness, colour, packaging resistance, rigidity, disgregability, etc.

(b) Materials and intermediate products: raw materials (active substances, excipient, adjuvant). Conditioning material. Special samples. Chemical products in the form of solutions or reagents for analysis.

Products: control charts, quality reports. Packaged, registered and stored chemical or pharmaceutical products. Samples.

d) Processes, methods and procedures: methods of physical (mechanical) testing of products. Methods of sampling. Methods of determining chemical properties. Computer recording and stock control methods.

e) Information: quality control standards, test procedures and instructions, control charts, quality control reports in progress. Warehouse schemes and signalisations. Marking of manufacturing lots. Labelling of products. Chemical applications of computer registration.

f) Personal and/or target organisations: Production Department (staff in charge). Quality control department. Department of purchases (suppliers) and sales department (customers).

Competition Unit 5: Meet and enforce the right manufacturing, safety and environmental standards of chemical-pharmaceutical processing

REALIZATION CRITERIA

5.1 Apply the main security measures in your production unit. /In the manufacturing guide has been described the personal protective equipment that should be used in each operation.

The operation of the protection and risk detection devices has been verified.

Compliance with safety standards has been proven in the loading and unloading of fluids and hazardous substances.

Security measures have been applied in the cleaning and maintenance of machines and appliances.

The order and cleaning rules that affect security have been arranged and expressed in the manufacturing guide.

The main points to be monitored have been detected in the commissioning of the equipment, in the tests to be carried out and in the production.

5.2 Control activity in different areas, depending on the specific risk, according to safety and hygiene rules at work. /It has been verified that the auxiliary services have worked correctly to filter air, to give positive pressure, etc., according to the necessary conditions in the area, according to the activity to be carried out and the product to be used.

Environmental trials have ensured that there is no risk of contamination.

Staff training has prevented pollution and has encouraged compliance with standards.

The individual protective equipment that must be used in each operation has been described in the manufacturing guide.

The protective equipment has been adequate to the degree of cleanliness or sterility of the area and the product to be manufactured.

The hygiene and hygiene standards prescribed in the manufacturing guide have been found to be observed.

Every person who has been detected disease or allergy has been prevented from participating in the manufacturing process and has been controlled to have passed periodic health checks.

It has been proven that staff working in clean areas maintain careful attitudes in movements, relationships, etc.

5.3 To verify compliance with environmental protection measures related to the production process. /Information has been obtained on the standards of environmental protection measures, be it laws, regulations, directives or internal rules.

The main points of the production or debugging equipment that affect the environment have been monitored.

The flow of water removed from the process has been monitored and, where appropriate, analyzed.

The air flowing from the process has been monitored and, where appropriate, analyzed.

5.4 Coordinate response activity to emergency situations. /An urgent initial assessment has been made of the risks that the emergency situation produced can be assumed for the people, the facilities and the production process.

When possible, you have communicated the situation to your superiors and acted in accordance with your instructions, giving in turn concrete instructions to the staff who are in your work area to execute the received.

Decisions have been made regarding the stopping of equipment and modifications of the manufacturing conditions when their urgency has required it, and the necessary instructions have been given to the staff in charge to carry them out.

The measures provided for in the emergency plan have been adopted and have been integrated into the organisation of the emergency plan, when it has become operational.

The actions have been performed with a logical course in an efficient and secure manner.

Professional Domain

a) Means of production: personal protective equipment (glasses, mask, gloves, sterile clothing). Protection and detection devices: gas leakage, fire, noise, radiation, washing eyes, thermometers, gauges, alarms. Machinery safety systems and transport equipment. Portable security detectors (thermometers, manometers, radiation detectors, noise detectors, specific gas detectors). Emergency devices for first aid or emergency response. Fire stairs, fire extinguishers, hoses, emergency lighting, danger signs. Environmental detectors: air, water, pHmeter, thermometers, etc. Water analysis equipment (physical, chemical and bacteriological). Air analysis equipment.

b) Materials and intermediate products: process water samples and products for their treatment. Air samples. Pharmaceutical or related products to be treated for disposal.

c) End-work products or results: effluents under conditions of disposal or waste for external treatment. Internal emergency plan and security in the process.

d) Processes, methods and procedures: processes for the purification and treatment of tributaries and effluents. Prevention techniques and methods of attack on the emergency. Methods of neutralizing corrosive and toxic products. Procedures for renetization.

e) Information: safety and environmental protection standards. Standard written procedures on safety, GMP and environmental protection. Manuals for the use of personal protective equipment. Manual of use of the prevention and attack teams to the emergency. Rules for the handling of pharmaceutical and related products.

f) Personal and/or target organisations: staff in your position. Department of maintenance. Quality control department.

2.2 Evolution of professional competence

2.2.1 Changes in technological, organizational and economic factors

Fine and pharmaceutical chemistry are the sectors of activity that the greatest job growth can have within the sector. It also appears that in these sub-sectors the dedication of resources to research and development will grow, in order to increase the added value of the products.

It will increase the automation and computer control of the warehouses as well as the use of automatons in the manufacturing processes that will allow the elimination of stocks in storage and therefore the optimization of the flow of materials.

This figure is in a type of advanced technology industry, applied to the handling and transformation of products and substances of great risk and added value, which implies a constant and increasing use of the concepts Performance/optimization and security/prevention.

2.2.2 Changes in professional activities

The economic and security factors, previously mentioned, are of particular importance in the activity of this professional who works in a batch production type, whose implementation and completion is usually responsible.

The production and conditioning machinery park requires special attention based on your cleaning and maintenance needs. Each equipment, once used must be cleaned according to established methods and overcome a quality control. Of the same importance as the cleaning, it is the maintenance of the equipment. Generally, these facilities have a high productivity and therefore the stoppages and breakdowns are critical. This technician has to know perfectly the machinery under his responsibility and must control/establish a user maintenance program, effective to ensure their productivity and work in contact with the maintenance departments engineering.

The safety of personnel and products will be another of the critical factors of their professionalism due to the fact that they work with active substances of biological and synthetic origin, susceptible to contaminating and being contaminated, which requires the enforcement of rigorous prevention measures.

Mission of this figure within the productive system is to form/report how it should be manufactured. Each production operation has a safety protocol and verification of good manufacturing standards, which must be followed. These standards and systems must be taught, subsequently controlled and constantly updated, following the advances of the technology and the needs of the company.

The collaboration with the quality department and, most importantly, considering itself a quality manager in its environment, will require to increase the technical capacity of these professionals, who must be able to propose continuous improvements in this field.

This figure, after covering the basic needs of organizing, conducting and optimizing processes, will have in the near future, more automated and flexible, greater importance in maintaining a good productive environment and must have ability to adapt to constant technological and organisational changes.

2.2.3 Changes in training

This figure should have clear and precise knowledge on statistical quality control, sampling techniques, interpretation of written procedures and protocols, documentation and safety and hygiene and Scientific and technical knowledge enabling it to receive further training and updating in such fields. Fitness to drive, lead teams as well as your knowledge of human relationships are of great interest in these positions and categories.

2.3 Position in the production process

2.3.1 Professional and work environment

This professional figure will exercise his activity in the chemical-pharmaceutical sector in the area of production and/or guarantee of quality.

The main subsectors in which you can develop your work are:

1. Manufacture of basic pharmaceutical products.

2. Manufacture of proprietary medicinal products and other pharmaceutical products.

3. Manufacture of pesticides.

4. Manufacture of colours.

5. Manufacture of essential oils.

6. Manufacture of perfumes and other products of beauty and hygiene.

The top technician in pharmaceutical and related products will be expected to be integrated into a production and conditioning line or equipment, actively participating in it and organizing the work, depending on the responsible for the production department.

In the activities related to the installation and adjustment of equipment, and quality control of products maintains a functional coordination and/or dependency with the responsible departments.

2.3.2 Functional and technological environment

This professional figure is mainly located in the functions/sub-functions of production, organization and programming, quality assurance and control in process.

Technology techniques and knowledge cover the field of fine chemistry and the mixing and processing of discontinuous process. They are directly linked to:

1. Chemical-pharmaceutical management: organization of human resources and production. Elaboration of instructions and reports. Performance and optimization of production. Chemical-pharmaceutical, safety and environmental legislation. Responsibility in quality. Use of applied computer systems.

2. Manufacturing process: set of equipment of a chemical plant or pharmaceutical laboratory of discontinuous process and of techniques of control of the equipment and control of the manufacture in batch and in campaigns.

3. Quality assurance: flow of materials in the production process. Online and laboratory controls of quality control of materials and products. Galenic forms. Knowledge of the characteristics and properties of the substances involved and the conditions necessary for their proper preparation, processing and conditioning.

4. Security with regard to the staff in charge (security courses, specific rules), the physical environment (facilities and systems, order and cleaning, protection of machines, personal protection, fire protection, transport and storage) and environment (toxicity, temperature, clean areas ...). Environmental protection: analysis of air and water.

Occupations, most relevant type jobs:

For example, and especially for the purposes of career guidance, a set of occupations or jobs that could be performed are listed below, acquiring the professional competence defined in the title profile: Head of Line. Team Head. Head of shift. Control technician. Process inspector. Warehouse coordinator. Construction contract. Manufacturing manager (envelopes, liquids, capsules and tablets, etc.). Conditioning counter.

3. Minimum teachings

3.1 General objectives of the training cycle

To assess the importance of the standards of correct manufacture of medicinal products, in the framework of quality management, as a means of compliance with the levels of safety, quality and efficacy of the products obtained and as an instrument for the inspection of the manufacture of medicinal products, for the influence on health of the use of pharmaceutical products.

Use correctly the terminology, symbology, instruments and apparatus of the production and quality control of pharmaceutical and related products to interpret the analytical and instrumental records, using the statistical and computer tools required for the analysis of results.

Describe an industrial pharmaceutical process and schematize it by means of a flow diagram, explaining the functioning of the different devices, the phases of transformation that the product undergoes and the function of the different controls to be installed as well as their form of regulation.

To analyze the risks inherent in the pharmaceutical industry, derived from cross-contamination, sterile conditions and the type of products being manipulated, as well as the means by which the pharmaceutical industry is used to to prevent risks to the staff that the factory and the people who consume them could take place.

Use with autonomy the strategies characteristic of the scientific method and, the procedures and know to make own of its sector, to make decisions in relation to concrete problems or practical assumptions, in function of data or known information, assessing the expected results of its performance.

Understand the legal, economic and organizational framework that regulates and conditions industrial activity, identifying the rights and obligations arising from industrial relations, as well as the mechanisms of employment insertion.

Apply the basic knowledge about the organization of work, in the orderly programming and evaluation of activities to assess their degree of difficulty and importance, and with this elaborate instructions The invention relates to a method for producing a method for producing the same and a method for operating the same.

Select and critically assess the various sources of information related to your profession, which allow you to develop your self-learning capacity and enable the evolution and adaptation of your skills (a) professionals in technological and organizational changes in the sector.

3.2 Professional modules associated with a Competence Unit

Professional Module 1: Organization and Management in Process Industries

Associated with Competition Unit 1: Organize the manufacture of pharmaceutical and related products

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

1.1 Analyze and develop the basic processes of chemical production, relating the basic and auxiliary phases and operations with the transformations of the material, and developing the process information that enables the processing of the processing operations. /Differentiate the continuous and discontinuous process types, identifying their characteristics from the perspective of their economy, performance and production control.

Explain the main techniques and equipment used in the production processes of oil refining, paper manufacturing, production of a medicine and water treatment.

From a diagram of any of the following manufacturing processes: oil refining, organic chemistry, paper manufacturing, drug manufacturing or inorganic chemistry:

-Identify the reagents, products, by-products and type of chemical reaction involved.

-Associate the application fields of the manufactured products.

-Isolate the parameters characteristic of each stage: nature of the phases, temperatures, pressures, concentrations, pH, ...

-Set a detailed diagram showing the different stages of the process and its chronology (recyclages, parallel treatments, ...).

-Set a balance of matter on the main manufacturing lines.

From a detailed description of the chemical process and the

:

-Set a process scheme in which the appliances (separation, mixing), equipment (pumps, compressors, exchangers, ...) and quality and safety control and regulation devices appear.

-Prepare for a given phase, the standard operating procedures, broken down and sequenced into work instructions, including at least specifications of:

+ Materials and chemicals.

+ Applicable Production Protocol.

+ Determination of operation and control conditions and parameters.

+ Where appropriate, useful and devices involved in their performance.

+ Sample sampling plan and description of the type of tests required.

+ Applicable security rules.

+ Instructions sheet or work tab.

+ Perform the calculation of the performance and economics of the process from the data in your operations.

+ Draw a scheme of a possible plant distribution of the process by justifying the adopted distribution.

1.2 Analyze the actions and documentation required for the planning and control of a batch chemical production. /From a type manufacturing process, with a given production cycle and an alleged customer delivery plan:

-Evaluate materials, identify devices, equipment and instruments involved in production.

-Describe the planning technique best suited to the characteristics of the production and lot.

-Define the documents needed to launch and control production.

-Apply software for the processing of production and control records.

1.3 Analyze the organizational and functional structure of the chemical industry. /Explain the functional areas of an oil refining, paper manufacturing, drug production and water purification industry and functional relationship between the various areas.

Explain through diagrams and organizational charts the internal organizational and functional relationships of the production area.

Explain through diagrams and organizational charts the external organizational and functional relationships of the production area.

Describe the flow of internal and external information regarding the security of the process of refining and manufacturing of pulp and paper.

Basic Contents (duration 90 hours)

a) Organization of chemical processes:

Process Types and . Schematization of manufacturing processes. Analysis of process diagrams, symbology.

Productivity and performance of chemical processes.

Interpretation of manufacturing techniques for oil refining processes, organic chemistry, inorganic chemistry, drug manufacturing, paper manufacturing: phases, basic and auxiliary operations of the type processes.

Documentation of the

: materials specifications. Pattern formulas. Pattern method. Conditioning instructions. Batch production protocols. Standard operating procedures.

Facilities and equipment plant layout.

b) Systems and working methods:

Working methods. The improvement of methods.

Study and organization of work. Analysis of tasks and job descriptions in the chemical and process industries.

Elaboration of for production.

c) Planning and control of continuous and batch production:

General concepts about production management.

Programming of a batch production. Methods.

The launch. Control of production progress.

Computer applications. Process control and production control programs.

d) The organizational and functional structure of the process industry:

Functional relations of the production department.

Objectives and sub-functions of production.

Professional module 2: Pharmaceutical plant areas and services

Associated with Competition Unit 2: Verify compliance of process equipment and conditions with established standards and specifications

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

2.1 Explain the environmental, structural and hygienic needs, which must be met by the pharmaceutical plants, relating to the prescribed quality conditions of the products. /From the technical information needed to develop a practical manufacturing scenario for a drug campaign:

-Identify local factors that need to be controlled (lighting, temperature, humidity, ventilation, insect protection, ...) to protect manufacturing.

-To analyze the cleaning and/or disinfection techniques of the premises that guarantee the level of cleanliness necessary for each genus of pharmaceutical products.

-Propose a redistribution of the premises, according to the manufacturing process, explaining the connection of the zones according to the sequence of processing operations.

Relate the characteristics of the interior surfaces of the site to the type of materials handled (dust, bulk, ...) and the type of cleaning required.

Justify the importance of lighting in production areas with visual controls, and ventilation/humidity in areas of heavy, sampling or processing of dry products.

Characterize the storage area as to its ordering system and conditions that must be controlled according to the stored material.

2.2 Describe the operation of the pressure and vacuum production equipment, relating the function they perform in the different production areas with the characteristics of the equipment. /Determine the requirements of pressure regulation in the production areas, making the necessary calculations to indicate the optimal values in each of them.

Describe the operating conditions of the pressure and vacuum equipment, and explain the maintenance schedule necessary for the start of the different production campaigns.

Justify the needs of the combined use of pressure-vacuum systems in the cleaning of equipment, for the processing and conditioning of pharmaceutical forms.

2.3 Analyze water purification equipment and appliances, used in the manufacture of pharmaceutical and related products, related to the needs of the production process. /To determine the possible treatments of the water, depending on the use to which it is to be used.

Explain the processes of distillation and demineralization of water, relating its indication in the preparation of reagents and in the execution of analytical methods.

Relate the criteria of chemical and bacteriological purity of water, identifying its parameters and limits, with the use and application of water to the process.

2.4 Evaluate the necessary characteristics of air for the air conditioning of zones or premises and relate them to the needs for the manufacture of sterile products. /To analyze the process of cleaning the air in the manufacturing premises of sterile pharmaceutical products, identifying the products and sterilizing agents for each phase of the process.

Explain the criteria for the classification of clean zones in their different grades, associating different types of production, with the required characteristics of the air.

Explain the process of air conditioning, relating the treatments (drying, humidification, purification), with the necessary equipment and its intervention during the manufacturing process.

2.5 Analyze the operation of heat generation and exchange equipment and explain their relationship and integration during the phases of the pharmaceutical manufacturing process. /Explain the operation of a type steam boiler, relating the different types of steam to be used in the production of spare specialties

nterales with these.

Explain the application of the physical principles of heat transmission to the operation of the refrigeration compressors and to the freeze-drying.

Basic Contents (120 hours)

a) The pharmaceutical (laboratory) plant:

General aspects of premises, buildings and spaces. Environmental conditions. Storage areas.

Special aspects: air conditioning, sterility, working habits in special areas (operational modes).

b) Heating and Cooling:

Concepts and units of heat and temperature. Measuring instruments. Heat transmission.

Status changes.

Heat generators, heat exchangers, and steam boilers

Physical principles. Operation of the equipment. Parameters of operation and/or control. Security devices. Identification of equipment.

Operation and control procedures and techniques. Analysis of real information of processes and equipment.

Operations for preparing, conducting and maintaining equipment at the laboratory and/or workshop scale. Regulation of pressure equipment.

Refrigeration: Cold production methods and equipment.

Application of thermal energy in pharmaceutical processing operations.

c) Water treatment for industrial processes and water:

Purification of water. Scheme of industrial facilities for obtaining purified water. Pharmaceutical quality water according to pharmacopoeias.

Water treatment plant: physical, chemical and microbiological treatments. Raw water treatment procedures for boilers, refrigeration and process. Procedures for the treatment of industrial waters. Direct measurement of water characteristics.

d) Treatment, transport and air distribution:

Composition and characteristics of the air as gas. Pressure, measurement and units.

Treatment, transportation, and air distribution facilities for general services and instrumentation. Final treatments.

Security conditions in the handling of gases.

Air Conditioning. Hygrometric state. Dehumidification and air humidification. Special areas.

Sterilization of air. Clean areas. Maintenance and control of sterility.

Professional Module 3: Pharmaceutical Process

Associated with Competition Unit 3: Coordinate and control the manufacture of pharmaceutical and related products

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

3.1 Relating the criteria for the classification of pharmaceutical products and related to production techniques and their applications. /explain the chemical or galenic nature of medicinal products and related products, in accordance with the origin of their raw materials and assess the importance of fine chemistry in the preparation of raw materials by methods of chemical and chemical synthesis biotechnology.

Classify pharmaceutical and related products according to their external or internal use, and their effects on the health and care of living organisms.

Characterize the qualitative composition, through the different terminologies, and the quantitative composition, expressed in different units, of the pharmaceutical and related products.

Distinguish official, masterful and industrial medicines, according to their method of preparation using pharmacopoeas.

3.2 To analyze and apply the techniques used in the galenic operations of preparation of raw materials and auxiliaries for the manufacturing process. /Explain the particle size reduction techniques to obtain the specific surface that favors the absorption of the product, by means of systems and equipment of spraying and micronization, defining the control parameters to obtain the product.

Solve problems of granulometric analysis of powders by sifting, performed their representation and using the criteria of classification of the different industrial sieves.

Characterize homogeneous and heterogeneous dispersed systems in relation to the pharmaceutical forms to which they may give rise and study the qualities of the solvent according to the solute to calculate the coefficient of solubility, and the dissolution rate, analyzing the factors that modify the solubility process and the technological resources for the solubilization.

Determine performance in an alleged liquid-liquid extraction process, calculating the distribution coefficient and the influence of the solubility of the components.

Determine the techniques of concentration of solutions, establishing the fundamentals and calculations of the balance of matter and energy, in the case of evaporation and desiccation, as well as the different equipment in which they are carried out.

Explain the foundation, phases, mode of development and consequence of lyophilization.

3.3 Put to the point and control in the workshop-laboratory a type of manufacture of pharmaceutical or related products, determining the process variables, the control parameters and observing the characteristics of the product specified in the pattern method and in the pattern formula. /Justify, through the process diagram of the manufacturing process, the different operations required in the elaboration of forms (solid, semi-solid or liquid), explaining its foundation and associating the variables of transformation with the properties of the material.

Characterize the technological requirements, whether they are of a pharmacotechnical type, of typing or therapeutic, that they must be contemplated in the preparation of the medication.

Explain the function of the systems and basic elements of the machines or equipment specific to the installation, represent them by means of a scheme and describe cleaning and adjustment techniques on the machines, estimating the parts criticism in their cleanliness.

From an assumption of manufacturing a batch of pharmaceuticals, including technical product and process information:

-Interpret the technical information of the product, identifying the qualities, shapes and units to be obtained.

-Define the characteristics of the raw and auxiliary materials used in the manufacture of the batch, according to its function, nature and use.

-From the standard formula, calculate the quantity of raw materials required according to the number of units in the batch, using the appropriate formulas and taking into account the pattern of preparation.

-Point the type installation, adjusting the variables of the manufacturing, using the measuring devices and control systems, to achieve the quality of the product.

3.4 Analyzing the techniques, equipment and operational modes required in the manufacture of sterile products and biotechnological products. /Interpret actual technical information about sterile manufacturing process diagrams, according to different methods by discriminating against the critical points of the process.

Distinguish the methods of sterilisation of products, packaging and prepared forms, as well as sterility control techniques.

Explain the modes of action of people who make sterile, to preserve the quality and safety of the product.

Describe a process-type of antibiotic manufacturing in relation to the development of microorganisms.

Relate biotechnology to the procurement of drug-action substances.

3.5 Relating the characteristics of the machines and equipment necessary for the process of dosing, packaging and packaging of pharmaceutical products with the product to be dosed and packaged. /To explain the different types of primary packaging, depending on the type of product, dosage and form of presentation, as well as the possible interactions between the continent and the content according to its properties.

Justify the technology applied in the dosing phase to maintain the constancy of the mass and the dose.

Determine the conditioning mode of various finished products, describing the stages marked in the manufacturing guide.

Enumerate the equipment used and the variables that must be regulated in the various equipment for the conditioning of products in solid phase, liquid or aerosol.

Relate the sources of contamination, by dust or bacteriological, in the product conditioning course, with the sterilization phases of products and packaging according to the various product preparation techniques sterile.

3.6 Analyze the steps of verification of a manufacturing order for a batch of pharmaceutical or related products.

From an assumption of manufacturing a batch of pharmaceutical and sterile products:

-Fill in the type manufacturing guide.

-Perform a report that contains data about the type of production, type of products, type of conditioning, and number of units produced.

-Define the materials or stages in the product report (qualitatively and quantitatively), personal (rest period, work and waits), machines (waiting period and use), and raw materials (packaging, physical aspects, reactions in the course of manufacture).

Appreciate the deviations in the control graphs of the manufacturing process and contrast it with the sampling values.

Basic Contents (duration 240 hours)

(a) Materials and materials used in manufacturing:

Raw materials: active principles. Classification by method of obtaining and by therapeutic groups. Components of the excipient. Function and importance. External coverage components.

Packaging and conditioning materials. Classification and characterization.

b) Pharmaceutical and related products:

Classification and importance for its health effects.

The rules of correct manufacturing of drugs applied to production. Basic regulations on pharmaceutical processes and pharmaceutical and related products.

c) Industrial gallic pharmacy operations in the preparation of materials for manufacture:

Physical or physicochemical principles of the operation. Industrial and laboratory scale equipment:

Solid size reduction.

Separation and classification of solids by their size. Sifting. Granulometry.

Homogeneous dispersed systems. Solutions. Suspensions and emulsions.

Filtration. Theoretical foundation and equipment.

Extraction by solvents. Object and embodiments.

Concentration of solutions. Balances and variants of desiccation and atomization.

lyophilization. Phases and development.

Conducting preparations for pharmaceutical and related products. Application of mixing and mixing techniques of mixtures in various aggregation states.

d) Industrial manufacturing of pharmaceutical and related products:

Phases of the manufacturing process: preparation, dosage and conditioning. Manufacturing formula. Validation of basic operations, industrial processes and installations.

Production diagram. Technology used. Product parameters and process variables. Phases and teams of:

Preparation of natural products used as active substances. Extractive preparations. Extracts and tinctures.

Manufacture of pharmaceutical products by the action of bacteria. Initiation of biotechnology.

Principles of immunology. Manufacture of antibiotics. Manufacture of vaccines.

Manufacture of pharmaceutical, cosmetic and related forms

Manufacture of powder, tablets and grasses.

Manufacture of suppositories, creams and ointments.

Manufacture of liquids. Spray.

Manufacture of sterile pharmaceutical products: parenteral, otic and ophthalmic.

Manufacturing and sterilization characteristics. Methods of manufacture and control of sterile pharmaceutical products.

Preparation at laboratory or pilot level of various pharmaceutical and related products with justification of the method used, calculations performed on the standard formula, followed procedure and yield obtained.

Professional Module 4: Quality Control in the Pharmaceutical Industry

Associated with Competition Unit 4: Ensuring the quality of pharmaceutical and related products in the process

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

4.1 Analyze the quality control systems used in the manufacturing process of pharmaceutical and related products.

Describe the quality management function by identifying its elements and the relationship with the company's goals and productivity.

Value quality as a parameter to obtain final products that are consistent with the specifications.

Identify the methodology, techniques and personnel associated with quality control of the pharmaceutical industry.

Interpret the analytical, toxicological and clinical standards and protocols in the field of drug testing.

4.2 Develop a quality control program applicable to the manufacturing process of finished and conditioned pharmaceutical and related products, in which the points, moments or frequencies in which it is necessary are determined carry out tests or quality control tests. /To identify the quality assurance systems of raw materials and pharmaceutical products, related, finished and conditioned.

Order and classify the chemical and biological products involved in the process, taking into account the physical, chemical and reactive properties, in terms of safety and quality, and making quality specifications of products.

Distinguish the different methods: manual, automatic or on foot of the machine, for the determination of the parameters of quality of the subject in process.

Assess the importance of the dosing, packaging and conditioning system in finished products as quality factors.

4.3 Relating the setting up of a pharmaceutical or related product with the operations of taking and preparing samples in the process of manufacturing or in storage. /Distinguish the main methods used for the manual or automatic sampling of a substance in a pharmaceutical process, be it starting materials, intermediate products, bulk or finished products.

Identify equipment and instruments for sampling according to the state and physical conditions of the matter.

Perform the sampling procedure, obtaining the sample in the appropriate container and keeping it in the conditions required by the nature of the sample and taking into account the operations to be performed and the precautions to be taken.

Mark the sample using the appropriate means to distinguish it from patterns, from other samples, and be aware of the importance of sampling in the pharmaceutical activity.

Set the frequency, as well as the conditions to be specified in a sampling procedure, incorporated into the manufacturing pattern method.

From a pharmaceutical and related product manufacturing process diagram:

-Identify the sampling points.

-Relate the control equipment of the subjects included in the control of the process.

-Determine the tests and tests to be performed in the laboratory.

Recognize the quarantine, rejection, and compliance zones related to sampling and testing that have occurred on the materials that are disposed in those zones.

4.4 Control the quality of finished products by physical testing. /Define the concepts of the main physical and physical-chemical properties, express the variables with the corresponding units, and solve changes of system units.

Make, with the help of simple devices, physical tests, handling the material correctly and respecting the safety measures, in order to verify whether these products respond to a quality specification.

Choose, between different techniques or instruments that measure the same variable, the one that best corresponds to the type of matter to be tested and to the precision or accuracy of the measure requested.

Recognize the limits of acceptance or rejection of the tested materials.

Analyze the organoleptic characteristics that should be considered in the verification of raw materials, conditioning elements and finished products according to their physical condition and presentation form.

4.5 Interpreting the main techniques of chemical and instrumental analysis used in quality control in the pharmaceutical process.

/Relate the information (measure) that the instrumental method provides with the properties that allow the concentration of a substance to be identified or measured.

Choose the appropriate technique, in time and place, for the determination of a preset parameter.

Calculate the percentage of the various ingredients in a finished product by measuring the amount of each of the active ingredients.

From data provided by the instrument, manually and/or automatically:

-List the validation stages of a quality control analysis of finished products, raw materials and conditioning elements.

-Present the data consistently and get results.

-Calculate physical or chemical factors by comparison with patterns or reference tables.

-Compare the results obtained with the rules and interpret them according to the quality specification provided.

-Approve or reject the results.

4.6 Control the effectiveness of sterilization methods and antimicrobial conservation agents as safety tests of the finished product. /Differentiate the variables to consider in the sampling of non-sterile (fertile) and sterile products.

List the (sterile) instruments used in sampling and relate them to the methods of sterilization of the sampling material and of the storage containers.

Choose a method of verification of sterilization efficiency according to the sterilization procedure (batch filtration, gas sterilization, dry heat, ionising radiation or water vapor), and verify the several critical factors that influence sterilization by the various methods.

Perform a test test (efficacy) of a bacteriostatic for a microbiological method including:

-Preparation of culture medium.

-Preparation of inoculation.

-Sampling.

-Mix of samples and inoculated.

-Incubation.

-Analysis and interpretation of the results.

List the types of safety tests and classes of substances on which a sterility test, bacterial endotoxins, pyrogens, or local tolerance in animals can be performed.

4.7 Recognising the criteria for determining the stability of a pharmaceutical form and the properties that may influence the formulation of pharmaceutical product standards. /Distinguish the physical properties and chemical properties of the active substances that may influence the pharmaceutical formulation.

Recognize the criteria and phenomena that influence the stability of the pharmaceutical forms.

Assess the influence of preservative and sterilant agents, as well as the packaging in contact with the product on the stability of the shape.

Propose and justify maximum tolerance limits for the content of the active substance in the finished product in relation to the expiry date, based on stability tests.

4.8 Develop technical reports of production or control of the pharmaceutical process, using data processing to obtain results by applying statistical techniques and making graphs. /From a set of data obtained experimentally with a particular method and with known precision instruments:

-Interpret the accuracy obtained with respect to the method and instruments used.

-To differentiate the accuracy of the experimental data with respect to the accuracy of the instrument.

-Determine possible errors and their causes according to the type of instrument and method used.

-Build data tables and represent them graphically on different scale types, performing the calculations required to express the variable on the set scale.

-Express results with the appropriate numbers based on accuracy.

Identify the elements that make up the report according to the objectives that are intended with its elaboration.

Compare results obtained with technical documents of parameters of the subject, identifying deviations from the forecasts.

Evaluate the results obtained, discriminating against those values that can be accumulated from those that must be rejected.

Make the report with the appropriate terminology and symbology, in the manufacturing industry of pharmaceuticals and related products.

Basic Contents (duration 120 hours)

a) Quality management and control:

Quality concept of a product and its measurement.

Quality in Product Design. Process change.

Quality assurance in supplier supplies. Sampling. Sampling techniques.

Quality in manufacturing. Process analysis. Variations in processes and their measurement. Data collection and presentation, statistics. Graphical representation. Control charts by variables and attributes.

The rules of correct manufacturing in relation to quality.

Spanish quality system standard.

Economic quality management. Quality costs. Quality improvement. Motivation

Manuals and quality systems.

Quality of delivery and service.

b) Establishment of standards for the development of a new product or improvement of an existing product:

Chemical, pharmaceutical and biological tests. Criteria for determining stability. Stabilisation and conservation agents. Proof of stability. Influence of the container in contact with the product.

Toxicological and pharmacological tests. Clinical research trials.

Establishment of standards for finished pharmaceutical products based on: physical properties, chemical properties, conditioning, storage conditions, use for treatment or diagnosis and pharmaceutical form.

c) Quality analysis and control of raw materials, conditioning elements and finished products:

Visual verification of organoleptic characters.

Measure of physico-chemical variables.

Identification and measurement of components using chemical or instrumental analysis techniques:

Derivative formation, by synthesis.

Electrical methods: potentiometry. Conductimetry. Colorimetry

Optical methods: refractometry. Polarimetry. Ultraviolet, Infrared Visible Spectrophotometry.

chromatographic methods.

Stages of validation of a quality control analysis: physical, chemical and microbiological parameters that must be controlled in the manufacture and as a finished product.

Conducting tests on solid, semi-solid, liquid forms with description of the test procedure, scheme of the equipment used, presentation of data obtained and treatment of the same, statistical and/or graphic. Justification for the results and conclusions.

d) bacteriological and biological control of pharmaceutical, cosmetic and related products:

Characterization of microorganisms. Cultivation, sowing and inoculation of microorganisms. Microscopic preparation and observation.

Efficacy trials of sterilization methods and antimicrobial conservation agents.

Professional Module 5: Chemical Safety and Environment

Associated with Competition Unit 5: Meet and enforce the right manufacturing, safety, and environmental standards of chemical-pharmaceutical processing

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

5.1 Analyze the security measures related to the prevention of risk arising from chemical materials. /To explain the safety measures related to the packaging, labelling and transport of chemical materials, relating them to the properties of the matter.

Classify chemicals from the perspective of their security or aggressiveness, identifying the security symbology associated with the product.

Identify the safety regulations applicable to the packaging, labelling and transport of chemical materials.

5.2 Analyze the safety measures related to the procedures and working methods of the chemical industry. /Relate the various individual protective equipment to the risk factors.

Explain the security measures regarding the maintenance of the facilities.

Relate order and cleanup rules to risk factors.

Make a scheme of the main safety signs of the chemical industry by relating the signaling to the risk factor.

Describe operational modes in classified areas of chemical risk.

Identify the risks of equipment and lines that work under pressure or vacuum, justifying preliminary tests and safety inspections prior to their implementation.

Identify the security regulations applicable to the work procedures.

Describe prevention measures against electrical current contact.

5.3 Analyze the systems, equipment, and devices used to prevent the risk arising from the chemical process, relating the systems and devices to risk factors and process operations. /Explain the operation of the process security control system, describing the operation and interaction of detectors, alarms and actuators.

Relate the function of process actuators to the variables and modifications they produce in their development.

From a chemical process diagram that incorporates the security system:

-Identify the security elements associated with the control system.

-Explain the function and justify the readiness of the alarm systems.

-Justify the redundancy of equipment as a security system.

5.4 To analyse the means necessary for the observation of environmental protection measures. /For a set of regulations and environmental standards given and from an alleged manufacturing or laboratory process with veniently characterized:

-Identify the essential aspects of the regulations applicable to the process.

-Identify parameters of possible environmental impact.

-Justify the provision and application of the detection and measurement devices of pollutants, such as surveillance networks, mobile equipment or analysis kits.

To assess the need and importance of emission control systems for the atmosphere, water purification and waste treatment, as a means of environmental protection and compliance with the standards and directives environmental.

5.5 Relating the hygienic risk factors derived from work in the chemical industry with its effects on health and with detection and/or measurement techniques and devices. /Classify chemical and biological contaminants by their nature, composition and effects on the organism.

Classify physical contaminants and microclimate derivatives of work by their nature and effects on the organism.

Make measurements of chemical, biological and physical contaminants with direct detection devices, interpreting the result of the measures in relation to the reference values of the applicable regulations.

Describe the detected detection and/or measurement devices.

Describe individual and collective protection measures that are characteristic of industrial activity.

Basic Contents (duration 60 hours)

a) Process and chemical job security:

Security techniques: evolution and approach.

Planning for preventive measures.

Risk analysis.

Security Signage.

b) Risk prevention:

Of the process: control system. Process security detectors. Alarms. Actuators on the process. Security actuators. Fault prevention systems in the control system.

Prevention of risk by chemicals. Safety signs in the packaging and labelling. Rules of order and cleanliness.

Prevention of industrial risks: contact with electrical current, maintenance of installations and equipment working under pressure or vacuum.

c) Measures and means of protection and response to the emergency:

Collective protection.

Personal protection equipment.

Emergency and response measures under emergency conditions:

Accidents at work: classification. Analysis of indices of accidents. Notification and registration of accidents. Methods for accident and incident investigation.

Fire and explosion: Driving, detection and protection.

Emergency plans: in front of fires. Equipment and techniques for extinction. In front of explosions. In the face of poisonings. In front of leaks and internal spills.

d) Prevention and protection of the environment:

Industrial hygiene. Prevention and protection of the working environment.

Physical, chemical and biological contaminants. Detection and measurement devices. Analysis and map of hygienic risks.

Pollution due to emissions into the atmosphere, waste water and solid waste. Emergency plan in the face of environmental pollution.

Treatment and Pollutant Measurement Techniques. Environmental regulations.

Use of clean technology for waste minimization.

3.3 Cross-sectional professional module: relationships in the workbench

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

Define, in the framework of a particular type of labor organization, the rules of operation (both collective and individual) of a team

people

to get the active participation of all its members. /Identify the roles of each of the group components.

Differentiate and characterize the level of responsibility of each of the participants of a particular work team.

Respect the opinions of other team members.

Assess the contributions provided by other colleagues.

Establish effective communication to assign tasks, receive instructions, and exchange ideas or information, solving potential situational questions that originate. /Identify the type of communicative process used in a message and the different strategies used to achieve good communication.

Classify and characterize the different stages of a communicative process.

Distinguish good communication that contains a clear message from another with divergent paths that disappear or entrenate the main objective of the transmission.

Deduct the alterations produced in the communication of a message in which there is disparity between the emitted and the perceived.

Analyze and assess interference that makes it difficult to understand a message.

Coping with conflicts that originate in the working environment, involving all members of the group in detecting the origin of the problem, avoiding making value judgments, and resolving the conflict by focusing on those aspects that can be modified. /Classify the different types of problems that can be presented in labor relations.

Relate the technical resources used to solve a particular problem.

Identify and apply the most appropriate solution capability to resolve a conflict.

Encourage and positively assess the participation of the other components of the group.

Making decisions, contemplating the circumstances that require making such a decision, and taking into account the opinions of others regarding possible solutions. /Identify and classify the possible types of decisions that can be used in a particular situation.

Analyze the circumstances in which you need to make a decision and choose the most appropriate one.

Apply the search method for a solution or response.

Respect and take into account the opinions of others, even if they are contrary to their own.

To exercise leadership within the framework of their professional competences, demonstrating their appreciation in an objective way and participating in decision-making, in the determination of activities, objectives, instruments and means, and in the allocation of tasks. /Identify and characterize the different models of leadership.

Analyze and assess the different situations the leader can encounter and the different forms or styles of intervention.

Driving and participating in meetings and/or discussions, reaching a relaxed and cooperative working environment of all participants. /List the most relevant objectives to be pursued in the group meetings.

Identify the different techniques of dynamization and operation of groups.

Discover the features of the most relevant techniques.

Relate each technique to the size and objectives of the group.

Basic Contents (duration 60 hours)

a) Business Organization Principles:

Address and coordination of actions of members of a group or team.

Key factors in the organization.

Basic components of a type business organization.

b) Information/communication processes:

Production of documents in which the tasks assigned to members of a team are contained.

Oral communication of instructions for the achievement of objectives.

Types of information/communication.

Elements of the communication process.

c) Labor relations:

Resolution of conflicting situations caused by labor relations.

Address and/or Leadership.

The conflict.

Decision making.

d) Group Dynamics:

Application of group dynamization techniques.

Group dynamics techniques.

Techniques for meeting address.

3.4 Vocational Training Module at Work Center

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

Elaborate process information regarding the manufacture of pharmaceutical products, achieving the feasibility of manufacturing. /Process information must include:

-The identification of equipment and materials involved in manufacturing.

-The description of the job stream and operations.

-The calculation of manufacturing times.

-The development of standard operating procedures for the manufacture of products.

-The description of the product quality specifications.

-The definition of the control tests in the process and their registration, and the determination of the control procedures.

-The description of the control devices and instrumentation. To put to the point, drive and control a process of manufacturing a pharmaceutical product and/or afin, guaranteeing the production and the quality of the product. /Interpret the procedures of the manufacturing guide.

Perform, on the installation itself, the necessary adjustments and adjustments, prior to the manufacture of the product.

Identify, where appropriate, the corrective maintenance needs of the installation.

Get the specified quality of the product, checking, by sampling and testing that the quality of the product corresponds to the specifications.

Propose modifications that come from the interpretation of the process control charts.

Apply the correct manufacturing rules and procedures on safety, hygiene and the environment. /Relate the clothes and personal protective equipment used in the different areas, with the hygienic risks to the people and the safety of the product.

Identify detection devices and protection systems that can be used in emergency situations.

To assess the importance of the prevention of cross-contamination and microbiological testing of the environment, in relation to the quality and safety of the product.

Behave responsibly in the workplace and integrate into the company's social-technical relations system. /Interpret and diligently execute the instructions you receive and take responsibility for the work you develop, communicating effectively with the right people at every moment.

Observe the internal procedures and norms of the working relationships established in the workplace and show at all times an attitude of respect to the company's command structure.

Analyze the impact of your activity on the production system and the achievement of the company's objectives.

Adjust to the established technical standards and procedures (process information, quality standards, safety standards, ...) by participating in improvements in quality and productivity.

Demonstrate a good professional practice, fulfilling the objectives and tasks assigned in order of priority with criteria of productivity and effectiveness in the work.

3.5 Professional training and guidance module.

TERMINAL CAPABILITIES/ASSESSMENT CRITERIA

Determine preventive and/or protective actions by minimizing risk factors and the consequences for the health and environment they produce. /Identify the most common risk situations in their field of work, associating the general techniques of action according to them.

Classify the damage to health and the environment according to the consequences and the most common risk factors that generate them.

Propose preventive and/or protective actions corresponding to the most common risks, which will reduce their consequences.

Apply immediate basic sanitary measures at the site of the accident in simulated situations. /Identify the priority of intervention in the case of several injured or multiple injured persons, in accordance with the criterion of greatest risk of injury.

Identify the sequence of measures that should be applied based on the existing lesions in the previous assumption.

Perform health techniques (CPR, quiesce, move ...), applying established protocols.

Differentiate the hiring modalities and apply insertion procedures in the work reality as an employed or self-employed person. /Identify the different forms of employment contracts that exist in the productive sector that allows the legislation in force.

In a given situation, choose and properly use the main job search techniques in your professional field.

Identify and properly fill in the necessary documents and locate the precise resources to be self-employed.

Orientate in the labour market, identifying their own abilities and interests and the most suitable professional itinerary. /To identify and evaluate the skills, attitudes and knowledge with professionalizing value.

Define the individual interests and their motivations, avoiding, where appropriate, the conditions for reasons of sex or other type.

Identify the training offer and the labor demand related to your interests.

Interpret the legal framework of the work and distinguish rights and obligations arising from industrial relations. /Use the basic sources of information of labour law (Constitution, Workers ' Statute, collective agreement ...) distinguishing the rights and obligations incumbent upon it.

Interpret the various concepts involved in a

.

In a class collective negotiation scenario:

-Describe the negotiation process.

-Identify variables (salary, security and hygiene, productivity, technology ...) object of negotiation.

-Describe the possible consequences and measures, as a result of the negotiation.

Identify social security benefits and obligations.

Interpret the data of the Spanish socioeconomic structure, identifying the different variables involved and the consequences of their possible variations. /From general economic information:

-Identify the main macroeconomic measures and analyze the relations between them.

Analyze the organization and economic situation of a company in the sector, interpreting the economic parameters that determine it. /Explain the functional areas of a company type of the sector, indicating the relationships existing between them.

From the economic memory of a company:

-Identify and interpret the most relevant economic variables involved in it.

-Calculate and interpret the basic ratios (financial autonomy, solvency, guarantee and financing of the fixed assets, ...) that determine the financial situation of the company.

-Indicate the possible financing lines of the company.

Basic Contents (duration 60 hours)

a) Health care:

Working conditions and security.

Risk factors: prevention and protection measures.

Safe work organization: general prevention and protection techniques.

First aid.

b) Legislation and industrial relations:

Labour law.

Social Security and other benefits.

Collective Bargaining.

c) Sociolaboral orientation and insertion:

The job search process.

Initiatives for self-employment.

Analysis and evaluation of professional potential and personal interests.

Formative/professional itineraries.

Non-discriminatory social habits.

d) Principles of economics:

Macroeconomic variables and socio-economic indicators.

International socioeconomic relations.

e) Economics and organization of the company:

The company: functional areas and organizational charts.

Economic operation of the company.

3.6 Baccalaureate materials that have been due to be cured to access the training cycle corresponding to this title:

+ Chemistry.

+ Biology.

+ Physics.

4. Teachers

4.1 Teacher Specialties to be taught by professional modules in the training cycle of "Manufacturing of pharmaceutical and related products"

Professional Module/Teacher/Body Speciality

1. Organization and management in process industries. /Analysis and Industrial Chemistry. /Secondary school teacher.

2. Pharmaceutical plant areas and services. /Process Operations. /F.P. Technical Professor

3. Pharmaceutical process. /Analysis and Industrial Chemistry. /Secondary school teacher.

4. Quality control in the pharmaceutical industry. /Analysis and Industrial Chemistry. /Secondary school teacher.

5. Safety and chemical environment. /Process Operations. /F.P. Technical Professor

6. Relationships in the workbench. /Training and Employment Guidance. /Secondary school teacher.

7. Training and Employment Guidance. /Training and Employment Guidance. /Secondary school teacher.

4.2 Materies and/or areas that may be imparted by the specialties of the faculty defined in this Royal Decree

Teacher/Body Materials/Specialty

Chemistry. /Analysis and Industrial Chemistry. /Secondary school teacher.

4.3 Qualifications of qualifications for teaching purposes

4.3.1 The equivalence is established for the purposes of teaching the titles of Doctor, Engineer, Architect or Licentiated with that of:

Technical Engineer in Industrial Chemistry;

Technical Engineer in Trash Industry,

for the delivery of the professional modules corresponding to the specialty of industrial analysis and chemistry.

4.3.2 The equivalence is established for the purposes of teaching the titles of Doctor, Engineer, Architect or Licenced with those of:

Diplomat in Business Sciences;

Diplomacy in Labor Relations;

Diploma in Social Work;

Diploma in Social Education,

for the delivery of the professional modules corresponding to the specialty of training and employment orientation.

5. Minimum requirements for teaching these teachings

5.1 Minimum space and facilities requirements

In accordance with Article 39 of Royal Decree 1004/1991 of 14 June 1991, the training cycle of higher-grade vocational training: "Manufacture of pharmaceutical and related products" requires the following minimum spaces: for your partition:

Spaces/Surface-m2/Utilization Grade-Percentage

Chemistry Laboratory. /90/25

Industrial Chemistry Workshop/180/45

Multipurpose Classroom/60/30

The degree of utilization expresses the percentage of space utilization (relative to the total duration of the cycle) by a group of students.

In the margin allowed by the "degree of utilization", the established training spaces can be occupied by other groups of students who will be able to attend the same or other educational courses, or other educational stages.

In any case, the learning activities associated with the training spaces (with the occupation expressed by the degree of use) may be carried out on surfaces used for other related training activities.

It should not be interpreted that the different learning spaces identified must necessarily be differentiated by means of closure.

6. Convalidations, correspondences and access to higher studies

6.1 Professional modules that can be subject to validation with occupational vocational training

-Pharmaceutical process.

Quality control in the pharmaceutical industry.

6.2 Professional modules that can be matched with work practice

-Pharmaceutical process.

-Quality control in the pharmaceutical industry.

-Job center training.

-Training and employment orientation.

6.3 Access to University Studies

-Diplomat in Nursing.

-Technical Engineer in Industrial Chemistry.