105. Regulation of the Federal Minister of Economics and Labour on vocational training in the teaching profession Pharmatnology (Pharmatnology-Training-Order)

On the basis of § § 8, 24 and 27 of the Vocational Training Act, BGBl. No. 142/1969, as last amended by the Federal Law BGBl. I No 5/2006, shall be arranged:

Teaching profession Pharmatology

§ 1. (1) The pharma technology teaching profession is set up with a teaching period of three and a half years.

(2) The terms chosen in this Regulation shall include the male and female form. In the teaching contract, teaching certificate, teaching letter and in the certificate of teaching qualification, the teaching profession is to be described in the form corresponding to the sex of the apprentist (Pharmatechnologist or Pharmatechnologin).

Professional profile

§ 2. Through vocational training in the teaching profession and in the vocational school, the apprentice trained in the teaching profession, Pharmattech, is to be able to carry out the following activities in a professional, independent and self-responsible way:

1.		Recipe-based selection and checking of the necessary raw materials and auxiliary materials as well as other required materials,
2.		Computer-aided process monitoring of production processes for the production of medical devices, including filling and packaging processes,
3.		Perform required process optimizations during production as well as capture technical data during the production process,
4.		Carry out process checks in compliance with the necessary GMP measures (good manufacturing practice) and quality management systems,
5.		Execute cleaning, process and packaging validations,
6.		Document all production-relevant data as well as their verification for completeness and accuracy,
7.		Carry out the work, taking into account the relevant safety rules, standards and environmental standards.

Professional image

§ 3. (1) The following vocational training programme shall be established for the training in the teaching profession in Pharma technology. The skills and knowledge referred to shall be conveyed, at the latest in the teaching year referred to in each case, in such a way as to enable the apprentice to pursue qualified activities in the sense of the professional profile, which shall, in particular: Independent planning, carrying out, controlling and optimising.

Pos.	1. Year of Teacher	2. Year of Teacher	3. Year of Teacher	4. Year of Teacher
1.	Knowledge of the operational and legal form of the teaching staff	-	-	-
2.	Knowledge of the organizational structure and tasks and responsibilities of the individual operating areas		-	-
3.	Introduction to the tasks, the branch position and the offer of the teaching establishment	Knowledge of the market position and the customer base of the teaching company
4.	Knowledge of work organisation, work planning and work design
5.	Knowledge of the ergonomic design of the workplace
6.	Knowledge of the rules on working hygiene and the right behaviour with regard to cross-contamination
7.	Handling and maintenance of the tools, machines, equipment and working tools to be used in the pharmaceutical industry
8.	Reading of technical documents such as sketches, drawings, plans, flow schemes, etc.
9.	Knowledge of materials and auxiliary materials, their properties, possibilities for use and processing possibilities
10.	Perform simple maintenance work as well as detect and eliminate faults in production machines and apparatus
11.	Knowledge of the pharmaceutical-specific working materials, in particular toxins, auxiliary substances and active substances, their properties, uses and processing possibilities, fields of application and the transition with safety data sheets
12.	-	-	Basic knowledge of preparations and preparation groups, active ingredient groups, dosage, administration, conditions of action, interactions, side effects, toxicology
13.	Knowledge and application of the company EDP (hard- and software)
14.	-	Use of information technology tools, such as personal computers, PC networks, Internet, databases, etc.
15.	Application of text processing and spreadsheet programs for the production of technical documentation, such as documentation and evaluations
16.	Basic knowledge of general and analytical chemistry as well as physics
17.	Knowledge of simple basic laboratory operations such as weighing, measuring, filtering, manufacturing solutions, temperature measurements, centrifuging, distilling, extraction	Perform simple basic laboratory operations such as weighing, measuring, filtering, producing solutions, temperature measurements, centrifuging, distilling, extracting		-
18.	Knowledge of the sampling of solid, liquid and gaseous substances as well as the implementation of operational sampling including sample preparation and preparation
19.	Knowledge of simple preparative and analytical work techniques such as density determinations, drying and annealing, pH-value and viscosity determinations, sorting and grading, sieve analyses, salary regulations		Perform simple preparative and analytical work techniques such as density determinations, drying and annealing, pH-value and viscosity determinations, sorting and classifying, sieve analyses, salary regulations
20.	Measurement of physical quantities in particular determination of material constants and substance properties		-	-
21.	-	Knowledge of the production, packaging and storage of solid pharmaceutical forms such as mixtures, granules, tablets, film-coated tablets, dragees, capsules and powders
22.	-	Knowledge of the production, packaging and storage of semi-solid pharmaceutical forms such as ointments and creams
23.	-	Knowledge of the production, packaging and storage of liquid pharmaceutical forms such as solutions, suspensions, emulsions and aerosols
24.	-	-	Knowledge of the production, packaging and storage of sterile pharmaceutical forms such as puncture bottles, sterile mixes, ampoules, solutions and lyophilisates
25.	-	-	-	Basic knowledge of biotechnological drug production
26.	-	Knowledge and cooperation in the selection and verification of raw materials and auxiliary materials and other materials required		Recipe for selection and verification of raw materials and other materials required
27.	Knowledge of the mechanical, thermal and pharmaceutical processes as well as the structure and function of the equipment, apparatus, machines and equipment required for this purpose		-	-
28.	-	Participation in the operation of the production plants for the production, filling and packaging of the company-specific drug forms		Operation of the production plants for the production, filling and packaging of the company-specific drug forms
29.	Knowledge of measuring, control and control technology		Knowledge of process control technology	-
30.	-	Measurement and reading of operating state variables such as pressure, level, flow rate, conductivity, pH value		-
31.	-	-	Computer-aided process monitoring, including filling and packaging processes, and execution of process controls and process optimizations as well as recording of operating data
32.	-	-	Documenting the data relevant to production as well as checking for completeness and correctness
33.	Knowledge of disinfection, sterilization, cleanliness zones, clothing, sterile filling, aseptic work, working under laminar flow as well as the room conditions such as overpressure, humidity and room temperature		Use in-company disinfection and/or Sterilisation process or Working with the operating purity conditions
34.	-	Knowledge of the implementation of cleaning, process and packaging validations including documentation		Carry out cleaning, process and packaging validations including documentation
35.	Knowledge of the GMP measures such as production hygiene and personnel hygiene		Applying the GMP measures such as production hygiene and personnel hygiene
36.	-	-	Basic knowledge of packaging development, packaging design, packaging material printing, packaging control and packaging properties
37.	Knowledge of the warehouses, warehouse regulations, storage conditions and logistics
38.	-	Logging and graphical evaluation of work results as well as their documentation also using the operational EDP and methods of statistics
39.	-	-	-	Planning of process, operating and working processes
40.	Basic knowledge of operational costs, their impact and their impact		-	-
41.	Knowledge of quality management measures		Cooperation in quality management
42.	Conduct discussions with superiors, colleagues, customers, suppliers and representatives of the authorities, with due regard for the appropriate language of expression
43.	-	Knowledge of the operational waste air and waste water treatment as well as the waste treatment		-
43a.	Knowledge of the company's specific environmental protection, the possibility of recycling and the essential requirements for the proper disposal of raw materials and other materials used during the operation
43b.	Knowledge of the use of protective equipment in production facilities
44.	Knowledge of operational fire and explosion protection as well as preventive fire and explosion protection measures
45.	Knowledge and application of the relevant English technical expressions
46.	Knowledge of the obligations arising from the apprenticeship contract (§ § 9 and 10 of the Vocational Training Act)
47.	Knowledge of the content and aim of the training, as well as essential training opportunities in this area
48.	The measures and regulations on the protection of the environment relevant to the teaching profession: basic knowledge of the operational measures for the sensible use of energy in the work-relevant work area; basic knowledge of the work-related work area residual substances produced and their separation, recovery and disposal of waste
49.	Knowledge of the relevant safety rules and standards, as well as the relevant rules for the protection of life and health
50.	Knowledge of first-time supply in case of occupational accidents
51.	Basic knowledge of the labour law provisions which are subject to the law

(2) In the course of training in the professional knowledge and skills (with special attention to the requirements and requirements of the company (in order to ensure that the apprentite's personality is formed in order to provide him with the necessary skills for a specialist), he/she must be able to Key qualifications in terms of social competence (such as openness, teamwork, conflict ability), self-competence (such as self-assessment, self-confidence, self-reliance, resilience), methodological competence (such as presentation skills, rhetoric in German language, comprehensibility in the broad guidelines of the The English language) and competence for self-directed learning (such as willingness, knowledge of methods, ability to select suitable media and materials) to be conveyed.

Rejecting Audit

Outline

§ 4. (1) The final examination is divided into a theoretical and a practical test.

(2) The theoretical examination comprises the subjects specialist, technology and applied mathematics.

(3) The theoretical examination shall not apply if the candidate for examination has reached the teaching objective of the last class of the professional vocational school or the successful completion of a vocational middle or higher school which replaces the teaching period has proven.

(4) The practical examination shall include the items of test work and expert discussion.

Theoretical examination

General provisions

§ 5. (1) The theoretical examination shall be carried out in writing. It can be carried out jointly for a larger number of test specimens, if this is possible without impairment of the test sequence. The theoretical examination can also be carried out in a computerised form, although all the essential steps for the examination board must be comprehensible.

(2) The theoretical test shall in principle be held prior to the practical examination.

(3) The tasks shall be in accordance with the scope and level of the purpose of the final examination and the requirements of the professional practice. They are to be explained separately to the examinees on the occasion of the task.

(4) The written work of the test specimen shall be marked accordingly.

Specialist

§ 6. (1) The audit shall include the substantive answer to tasks in the following areas:

1.		General, inorganic and organic chemistry,
2.		Manufacture and packaging of medicinal products,
3.		quality management,
4.		Pharmaceutical documentation.

(2) The test can also be checked in programmed form with questionnaires. In this case, six tasks are to be carried out in each area.

(3) The tasks shall be carried out in such a way that they can normally be carried out in 60 minutes.

(4) The test shall be terminated after 80 minutes.

Technology

§ 7. (1) The audit shall include the substantive answer to tasks from all the following areas:

1.		Pharmaceutical process engineering for the production of solid, liquid, semi-solid and sterile drugs,
2.		Measurement technology and material constants,
3.		Function and application of various types of pharmaceutical products,
4.		packaging technologies,
5.		Warehouse and warehouse order.

(2) The test can also be checked in programmed form with questionnaires. In this case, six tasks are to be carried out in each area.

(3) The tasks shall be carried out in such a way that they can normally be carried out in 60 minutes.

(4) The test shall be terminated after 80 minutes.

Applied mathematics

§ 8. (1) The audit shall include tasks from all the following areas:

1.		Pharmas-specific calculations,
2.		Material constants and their applications,
3.		Pharmaceutical Process Engineering,
4.		Metrology,
5.		Packaging of medicinal products.

(2) Use of calculation instructions, tables and formulas is allowed.

(3) The tasks shall be carried out in such a way that they can normally be carried out in 60 minutes.

(4) The test shall be terminated after 80 minutes.

Practical examination

Audit work

§ 9. (1) The examination must be carried out in the form of the processing of an operational work order, after the examination board has been specified.

(2) The task is to carry out a company work order (from the field of pharmaceutical production using process steps such as granulation, tabletting, drying, screening, filling, packaging), including: from work planning, safety and health measures at work, if necessary, to take the necessary measures to protect the environment and quality control measures. The individual steps in the execution of the task are to be documented manually or computer-based. The examination board can provide the examinee with appropriate documents on the occasion of the task.

(3) The Examination Committee shall, on the basis of the purpose of the final examination and the requirements of the professional practice, place a task on each test item, which can normally be carried out in seven hours.

(4) The examination shall be terminated after eight hours.

(5) The evaluation shall be based on the following criteria:

1.		Professional use of equipment, apparatus, machinery and equipment,
2.		Professional guidance of working documents,
3.		Order and cleanliness of the implementation.

Expert discussion

§ 10. (1) The expert interview shall be submitted before the entire examination board.

(2) The expert discussion has to be developed from the practical activity. In this case, the practical knowledge of the test specimen can be determined using technical expressions. The examinee shall present subject-related problems and their solutions, demonstrate the technical background relevant to the contract and justify the procedure in the performance of the contract. The examination is in the form of a conversation that is as lively as possible, with a call for discussion by means of the description of situations and problems.

(3) The purpose of the topic is to correspond to the purpose of the final examination and to the requirements of the professional practice of the test specimen. Here, material samples, tools, demonstration objects or display boards are to be used. Questions on relevant safety regulations, protection measures and accident prevention should be included.

(4) The expert discussion shall take 20 minutes for each test specimen. An extension of not more than ten minutes shall be carried out on a case-by-case basis if the examination board is not otherwise able to assess the performance of the test specimen without a doubt.

Repeat Review

§ 11. (1) The final examination of the Lehrabate can be repeated.

(2) If up to two items have been rated "Not sufficiently", the repeat examination shall be limited to the items rated "Not enough".

(3) If more than two items have been rated "Not enough", the entire test shall be repeated.

Restricted Additional Check

§ 12. According to § 27 (2) of the Vocational Training Act, a limited additional examination in the teaching profession of pharma technology can be filed after successfully completed examination of the teaching profession in chemical process engineering or chemical warrior. This extends to the subject-matter discussion. § § 10 and 11 shall apply mutatily for this additional examination.

Final provisions

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

Bartenstein