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The aim of the course is to familiarize students with the philosophy of setting good manufacturing practice requirements. There are also discussed various topics related to procedures and methods needed and used to keep the process under control and proof of this fact, the regulatory authorities.
Last update: TAJ111 (03.12.2013)
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Students will be able to: •understand the basic way of defining the requirements for production according to GMP •create basic types of production documentation •propose procedure validation process according to standard principles Last update: TAJ111 (03.12.2013)
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R: Cloud P.: Pharmaceutical Equipment Validation, Interpharm Press, 1998, 1574910795 R: Mindy J. Allport-Settle : Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union, EudraLex Volume 4 Concise references, PharmaLogika, 2009 A: ISPE Baseline Guide: Volume 4: Water and Steam Systems, 2001 A: Heating, Ventilation, and Air Conditioning (HVAC) (ISPE Good Practice Guide), 2009 A:Food and Drug Administration: Process Validation: General Principles and Practices; 2011 A:Organizational and methodological instruction SUKL, VYR-26 and VYR-32, incl. supplements 1,9,11,13,15 A: Donald M. Rosendale : Validation of Pharmaceutical Process Equipment, Last update: Durdil Petr (07.08.2013)
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Act of Pharmaceuticals, No. 70/2013 Coll. Journal of Validation Technology, IVT, 2009-2013 Pharmaceutical Engineering, The Official Technical Magazine of ISPE, 2011-2013 Metrology law ; No. 119/2000 Coll. CSN EN ISO 9001:2009 (QM); 13485:2012 (QM); 14001: 2005 (EMS) Czech Pharmacopoeia 2009 incl. supplements Last update: Durdil Petr (07.08.2013)
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1. Good manufacturing practice in pharmaceutical and chemical manufacturing 2. Industrial production of drugs 3. Processes in pharmaceutical manufacturing 4. Process Analysis 5. Documentation and documentation systems 6. Management and monitoring processes 7. Fundamentals of Metrology 8. Measuring Systems 9. Validation processes 10. Cleaning and sanitation 11. Highly active substances and their classification 12. Water systems in pharmacy 13. HVAC, clean and defined spaces 14. Hygiene, Safety and Environmental Protection Last update: Durdil Petr (07.08.2013)
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Engineering in the Pharmaceutical Industry - required Registration of Drugs and Patent Protection - recommended Last update: Paterová Iva (18.02.2016)
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| Teaching methods | ||||
| Activity | Credits | Hours | ||
| Účast na přednáškách | 1 | 28 | ||
| Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi | 0.5 | 14 | ||
| Příprava na zkoušku a její absolvování | 1.5 | 42 | ||
| 3 / 3 | 84 / 84 | |||
| Coursework assessment | |
| Form | Significance |
| Regular attendance | 20 |
| Examination test | 80 |