Quality Assurance

Compulsory Course

• in BSc Applied Biology, 4^th Semester
• 2h/week (1L/1E/0P)
• Credits: 3 ECTS

Learning outcomes:

At the end of the lecture the students are able:

• to understand the principles of the Good Manufacturing Practice (GMP).
• to describe GMP is an international requested documentation system in the areas of finished medicinal products and cosmetics.
• to implement this knowledge within the bounds of production and quality control of the pharmaceutical and cosmetic industry.
• to control the processes’ validity and their robustness.
• to control the efficiency of the performance of analytical equipment by using validated documentation systems.

Content:

• Basic concept and requests of Good Manufacturing Practice
• Admission procedure of finished medicinal products (Specification and examination regulations)
• Standard Operating Procedures (SOP)
• Production (Staff, rooms, process control)
• Production (Cleaning- and process validation)
• Quality control (Sampling, reagents, standards, methods, documentation, ooS results)
• Quality control (staff, training, job description, double check, audits)
• Quality control (Stability testing)
• Qualification of analytical equipment (Planing/types of tests: GAP, FMEA, V-Modell)
• Qualification of a climate chamber (practical realisation)