Cílem předmětu je seznámit studenty s filozofií souboru požadavků Správné výrobní praxe. Dále jsou probírány jednotlivé tématické okruhy, které se týkají postupů a metod potřebných a používaných pro udržení procesu pod kontrolou a doložené této skutečnosti regulačním autoritám.

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.

Studenti budou umět:

• orientovat se základním způsobem v požadavcích na výrobu podle GMP

• zpracovat základní typy výrobní dokumentace

• navrhnout postup validace procesu podle předepsaných podmínek

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

Z: Cloud P.: Pharmaceutical Equipment Validation, Interpharm Press, 1998, 1574910795

Z: 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

D: ISPE Baseline Guide: Volume 4: Water and Steam Systems, 2001

D: Food and Drug Administration: Process Validation: General Principles and Practices; 2011

D: Organizačně metodický pokyn SÚKL, VYR-26 a VYR- 32 ,vč. Doplňků 1,9,11,13,15

D: Donald M. Rosendale : Validation of Pharmaceutical Process Equipment,

D: Heating, Ventilation, and Air Conditioning (HVAC) (ISPE Good Practice Guide), 2009

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,

Zákon o léčivech, č. 70/2013 Sb.

Journal of Validation Technology, IVT , 2009-2013

Pharmaceutical Engineering, The Official Technical MagaziE of ISPE, 2011-2013

Zákon o metrologii ve znění zákona č.119/2000 Sb.

ČSN EN ISO 9001:2009 (QM ); 13485:2012( QM); 14001: 2005 (EMS)

Český lékopis 2009, vč. Doplňků

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

1. Správná výrobní praxe ve farmaceuticko-chemické výrobě

2. Průmyslová výroba léků

3. Procesy ve farmaceutické výrobě

4. Analýza procesů

5. Dokumentace a systémy dokumentování

6. Řízení a monitoring procesů

7. Základy metrologie

8. Měřící systémy

9. Validační procesy

10. Čistící a sanitační procesy

11. Vysoce účinné látky a jejich klasifikace

12. Vodní systémy ve farmacii

13. Čisté a definované prostory

14. Hygiena, bezpečnost a ochrana prostředí

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

Inženýrství farmaceutických výrob - povinné

Registrace léčiv a patentová ochrana - doporučené

Engineering in the Pharmaceutical Industry - required

Registration of Drugs and Patent Protection - recommended

Quality Assessment and Quality Assurance in Chemical Technology is the subject from the area of industrial application of engineering and technological processes. Lectures are designed based on good manufacturing practice and engineering principles of chemical-pharmaceutical production. The course deals with the manufacturing conditions and production processes control to achieve the desired product quality.

You will learn how to approach to the task of preparing the realization of pharmaceutical manufacturing units.

Creating a simple study will be a part of the exam. A task will be specified at the second lecture. The study will be processed collectively in the five-member teams. The composition of the teams is up to your choice. Each member of the team will discuss the resulting study separately during the oral exam. The study must be available no later than 1 day before your exam. There are reserved two consultation during lectures.

The exam will consist of the written test (held at the time of the lecture in the last week of semester) for which you can receive up to 20 points and from the studies discussion you can receive up to 30 points. The final grade will be based on the sum of points from both parts.

grade points

A 50 45

B 44 40

C 39 35

D 34 30

E 29 25