Pharmaceuticals Education Regulations

Original Language Title: Pharmatechnologie-Ausbildungsordnung

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Get a Day Pass for only USD$9.99.
105. Regulation of the Federal Minister for Economics and labour about the vocational training in the teaching of pharmaceuticals (pharmaceuticals training rules)

On the basis of §§ 8, 24 and 27 of the vocational training Act, Federal Law Gazette No. 142/1969, as last amended by the Federal Act Federal Law Gazette I no. 5/2006, is prescribed:

Teaching pharmaceuticals



§ 1 (1) the teaching of pharmaceuticals is decorated with an apprenticeship of three and a half years.

(2) the terms in this Regulation include the male and female form each. The teaching profession in the form of the corresponding to the gender of the apprentice (metallurgy or Professor) is in the teaching certificate, apprenticeship, vocational and apprenticeship completion certificate.

Professional profile



§ 2. Through the vocational training in teaching and in the vocational school, the apprentice trained in the teaching of pharmaceuticals should be enabled to be able to perform the following activities independently, professionally and independently:



1. Rezepturgemäßes selecting and verifying the required raw materials and Excipients, as well as other required materials, 2. computerized process monitoring of production processes for the production of medicinal foods including filling and packaging processes, 3. make necessary process optimization during production as well as collect technical data during the course of the production, 4. performing process controls in compliance with measures GMP (good manufacturing practice) and quality management systems, performing cleaning, process and packaging validation 5. , 6 documenting of all production-relevant data, as well as their review for completeness and accuracy, 7 run of work, taking into account the relevant security regulations, and environmental standards.

Professional image



Section 3 (1) for the training in the teaching of pharmaceuticals is is to set the following job description. The specified skills and knowledge are starting to give graduates the apprentice to carry out qualified activities on behalf of the career profile that includes in particular independent planning, performing, check and optimize at the latest in the specified year.

 







POS.









1st year of training









2. year of apprenticeship









3rd year of training









4. year of apprenticeship









1.





Knowledge of the operational and legal form of the institution





































2.





Knowledge of the organizational structure and the roles and responsibilities of each operating area



























3.





Introduction to the tasks, industry position, and the offer of the teaching





Knowledge of the market position and the customer base of the institution







4.





Knowledge of work organisation, work planning and organisation of work







5.





Knowledge of the ergonomic design of the workplace







6.





Knowledge of occupational hygiene rules and the correct behaviour with regard to cross contamination







7.





Manage and maintain the to use tools, machines, equipment and work AIDS in pharmaceutical production







8.





Read technical documents such as sketches, drawings, plans, Fliessschematas, etc.







9.





Knowledge of materials and auxiliary materials, their properties, uses and processing possibilities







10.





Perform simple maintenance work as well as detect and resolve errors on production machines and apparatus







11.





Knowledge of pharmaspezifischen of agents, in particular toxic substances, auxiliary and active ingredients, their properties, uses and processing capabilities, applications, as well as the commitment to safety data sheets







12.

























Basic knowledge of products and product groups, groups of active ingredients, dosage, administration, impact conditions, interactions, side effects, toxicology







13.





Knowledge and application of the operational data processing (hardware and software)







14.















Use of information technology tools, such as personal computers, computer networks, Internet, databases, etc.







15.





Application of word processing and spreadsheet application for creating technical documentation such as documentation and evaluations







16.





Basic knowledge of General and analytical chemistry and physics







17.





Knowledge of simple laboratory technical operations such as weighing, measuring, filtration, creating solutions, temperature measurements, centrifuging, distilling, extract





Perform simple laboratory technical operations such as weighing, measuring, filtration, producing solutions, temperature measurements, centrifuging, distilling, extract

















18.





Knowledge of sampling of solid, liquid and gaseous substances, as well as performing operational sampling including sample preparation and processing







19.





Knowledge of simple preparative and analytical techniques such as density determinations, drying and annealing, pH and viscosity terms, sorting and grading, sieve analysis, content rules





Perform easier preparative and analytical techniques such as density determinations, drying and annealing, pH and viscosity terms, sorting and grading, sieve analysis, content rules







20.





Measuring physical quantities in particular determination of material constants and properties of substances



























21.















Knowledge of production, packaging and storage of solid dosage forms such as mixtures, granules, tablets, film-coated tablets, coated tablets, capsules and powder







22.















Knowledge of the production, packaging and storage of semi-solid dosage forms such as ointments and creams







23.















Knowledge of the production, packaging and storage of liquid dosage forms such as aerosols, solutions, suspensions and emulsions







24.

























Knowledge of production, packing and storage of sterile dosage forms such as puncture vial, sterile mixes, vials, solutions and are







25.



































Basic knowledge of biotechnological production of active ingredient







26.















Knowledge and collaboration in the recipe urgemaessen selection and validation of raw and auxiliary materials and other necessary materials





Recipe-urgemaesse selection and validation of raw and auxiliary materials and other necessary materials







27.





Knowledge of mechanical, thermal, and pharmaceutical procedures as well as the structure and function of devices necessary, devices, machines and systems



























28.















Participation in the operation of the production facilities for the production, filling and packaging of the company-specific dosage forms





Operation of the production facilities for the production, filling and packaging of the company-specific dosage forms







29.





Note of the measuring -, steering - and control technology





Knowledge of process control engineering

















30.















Measuring and reading by state size such as pressure, level, flow, conductivity, Ph

















31.

























Computer-aided process control including filling and packaging processes and perform process controls and process optimisation and recording of operating data







32.


























Documenting the production-relevant data, as well as their review for completeness and accuracy







33.





Knowledge of disinfection, sterilization, purity zones, clothing, sterile bottling, aseptic work, of working under laminar flow as well as the room conditions like pressure, humidity and room temperature





Applying operational disinfection or sterilization procedures or working with the operational conditions of purity







34.















Note of the implementation of process -, cleaning and packaging validation including documentation





Perform cleaning, process and packaging validation including documentation







35.





Knowledge of the GMP measures such as production hygiene and personal hygiene





Applying the GMP measures such as production hygiene and personal hygiene







36.

























Beginner Pack development, Pack media design, Pack media printing, Pack central control and packaging material properties







37.





Knowledge of bearings, bearing right, storage conditions and logistics







38.















Logging and graphic evaluation of work results and the documentation including the application of operational data processing and statistical methods







39.



































Planning process, operations and processes







40.





Basic knowledge of the operating costs, their influence and their effects



























41.





Knowledge of the quality management measures





Involvement in quality management







42.





Holding a conversation with superiors, colleagues, customers, suppliers and authorities in accordance with the correct idiom







43.















Knowledge of company-specific exhaust and waste water treatment and waste treatment

















43A.





Knowledge of the operational environment, the possibility of recycling and the main provisions of the proper disposal of the raw materials used in the operating and auxiliary materials, and other materials







43 (b).





Note of the use of protective equipment in the production facilities







44.





Knowledge of operational fire - and explosion protection, as well as the preventive fire - and explosion protection measures







45.





Knowledge and application of relevant English terms







46.





Knowledge of the obligations arising from the apprenticeship contract (§§ 9 and 10 of the vocational training Act)







47.





Knowledge content and aim of the training as well as significant relevant training opportunities







48.





The teaching profession-relevant measures and regulations to protect of the environment: basic knowledge of operational measures for the sensible use of energy in terms of profession-related work; Basic knowledge of the residues covered work relating to job-related and their separation, recycling and disposal of waste







49.





Knowledge of the relevant safety regulations and standards, as well as the relevant provisions for the protection of life and health







50.





Knowledge of primary care at company-specific work-related accidents







51.





Basic knowledge of the notice requiring labour legislation





(2) for the training in the professional knowledge and skills (with particular attention to the operational needs and requirements (on the personality education of the apprentice to make sure to give him the key qualifications required for a specialist with regard to self-competence (such as self-assessment, self-confidence, self-reliance, resilience), social skills (such as openness, teamwork, conflict resolution skills), methodological competence (such as presentation skills, rhetoric in the German language, communication ability in the fundamentals of the English language) and competence for self-directed learning (such as standby)) , Knowledge of methods, ability to choose of appropriate media and materials) to mediate.

Final apprenticeship examination

Outline



4. (1) divided the final apprenticeship examination in a theoretical and a practical test.

(2) the theoretical exam items includes expertise, technology and applied mathematics.

(3) the theoretical test is omitted if the candidate has demonstrated the goal of teaching the last class of technical vocational school or the successful completion of a vocational middle or higher school replacement of the apprenticeship.

(4) the practical examination includes the items of inspection work and consultation.

Theory test

General terms and conditions



§ 5 (1) has the theoretical exam in writing. She can be performed together for a large number of specimens, if this is possible without affecting the course of the examination. The theoretical exam can be in computerised form, but all essential steps for the examination Board must be comprehensible.

(2) the theory test is basically before the practical test to hold.

(3) the tasks have the purpose of the final apprenticeship examination and the requirements of professional practice to meet scope and level. You are to explain the specimens on the occasion of the tasks separately.

(4) the written works of the sample are to be marked accordingly.

Vocational skills



Section 6 (1) has the test to include the brief responding to tasks in the following areas:



1 General, inorganic and organic chemistry, 2. manufacture and packaging of pharmaceuticals, 3. quality management, 4 pharmaceutical documentation.

(2) the test can be checked in the programmed form with questionnaires. In this case, six tasks to make are from each area.

(3) the duties are to provide that they can be performed usually in 60 minutes.

(4) the examination is to finish after 80 minutes.

Technology



Section 7 (1) has the test to include the brief responding to problems in all the following areas:



1 pharmaceutical process technology for the production of solid, liquid, semi-solid and sterile drugs, 2. Metrology and material constants, 3. function and application of various pharmaceutical equipment, 4. packaging technologies, 5. bearing and bearing right.

(2) the test can be checked in the programmed form with questionnaires. In this case, six tasks to make are from each area.

(3) the duties are to provide that they can be performed usually in 60 minutes.

(4) the examination is to finish after 80 minutes.

Applied mathematics



8. (1) has the examination to include items from all the following areas:



1 Pharmaspezifische calculations, 2. material constants and their applications, 3 pharmaceutical process engineering, 4. metrology, 5. packaging of medicines.

(2) the use of computer AIDS, tables and formulas is allowed.

(3) the duties are to provide that they can be performed usually in 60 minutes.

(4) the examination is to finish after 80 minutes.

Practical exam

Audit work



§ 9 (1) is the test according to the Commission in the form of making a business work order processing.

(2) the task focuses on the implementation of an operational working order (from the pane, under application of process steps such as granulation, tableting, drying, seven, bottling, packaging, drug manufacturing), including work planning, measures for the safety and health protection at work, to extend any required environmental protection measures and measures of quality control. The steps of the task are manualy or computer-based document. The Audit Commission can make available for that purpose the appropriate documents the DUT on the occasion of the task in hand.

(3) the examination Board has under consideration on the purpose of the final apprenticeship examination and the requirements of professional practice to put a task each test specimen which can be run in seven hours.

(4) the examination is to end after eight hours.

(5) for the review, the following criteria shall apply:



1. proper use of devices, apparatus, machines and equipment, 2. proper execution of work documents, 3rd order and cleanliness of the implementation.

Technical discussion



§ 10 (1) is the technical discussion to place before the entire Commission.


(2) the consultation is to develop practical activities out. This practical knowledge of the DUT using technical terms should be noted. The DUT has represent subject-related problems and their solutions, provide information on the professional backgrounds relevant to the job and to establish the procedure for the execution of the order. The test is in the form of a possible living conversation with conversation default by portrayal of situations and problems.

(3) the topic has to correspond to the purpose of the final apprenticeship examination and the needs of the professional practice of the test specimen. Here are samples, tools, to attract demonstration objects or boards. Questions about relevant safety regulations, safety measures and accident prevention are to be included.

(4) the consultation should take 20 minutes for each test specimen. An extension to a maximum of ten minutes shall be made if otherwise a doubtless assess of the performance of the test specimen is not possible the examination Board in individual cases.

Repeat test



11. (1) the final apprenticeship examination can be repeated.

(2) if evaluated up to two items with "Not enough", the repeat testing on the items with "Insufficient" is to limit.

(3) If more than two items with "Not enough" have been assessed, is the entire test to repeat.

Limited additional testing



§ 12. After successfully final apprenticeship examination in teaching chemical engineering or architect a limited additional check in the teaching profession of pharmaceuticals can be dropped in accordance with sec. 27 paragraph 2 of the vocational training Act. Covering technical discussion on the subject. For this additional test, the pursuant to sections 10 and 11 shall apply mutatis mutandis.

Final provisions



§ 13. This Regulation shall enter into force April 1, 2008.

Bartenstein

Related Laws