SubjectsSubjects(version: 902)
Course, academic year 2021/2022
Quality Assessment and Quality Assurance in Chemical Technology - B111010
Title: Jištění kvality technologických procesů
Guaranteed by: Department of Organic Technology (111)
Actual: from 2021
Semester: summer
Points: summer s.:3
E-Credits: summer s.:3
Examination process: summer s.:
Hours per week, examination: summer s.:2/0 [hours/week]
Capacity: unlimited / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
For type:  
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: Durdil Petr Ing. CSc.
Paterová Iva Ing. Ph.D.
Interchangeability : N111042
This subject contains the following additional online materials
Annotation -
Last update: Hladíková Jana (03.01.2018)
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.
Aim of the course -
Last update: Hladíková Jana (03.01.2018)

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

Literature -
Last update: Hladíková Jana (03.01.2018)

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,

Learning resources -
Last update: Hladíková Jana (03.01.2018)

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

Syllabus -
Last update: Hladíková Jana (03.01.2018)

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

Registration requirements -
Last update: Hladíková Jana (03.01.2018)

Engineering in the Pharmaceutical Industry - required

Registration of Drugs and Patent Protection - recommended

Course completion requirements -
Last update: Paterová Iva Ing. Ph.D. (22.02.2018)

Course is finished by exam consisting of written and oral part (defense of the project). Project is submitted 2 days before exam. Unexcused absence in the term or unsubmitted project are evaluated by grade F.For details see e-learning.

Teaching methods
Activity Credits Hours
Konzultace s vyučujícími 0,2 6
Účast na přednáškách 1 28
Práce na individuálním projektu 1 28
Příprava na zkoušku a její absolvování 0,8 22
3 / 3 84 / 84