For students of the Master course "Pharmaceutical and Industrial Biotechnology"
Goals and content of this lecture:
- Understand what quality means, how it is attained and how it is controlled in drug and drug substance production.
- Content by major keywords: Quality, Specifications, QM, QA, QC, Qualification, Validation, GMP, ICH, Registration, Eudralex, Pharmacopeias (Ph.Eur., USP), Analytical lifecycle of a drug.
- Last two classes: Student presentations of examples of guidelines and other regulatory documents and of analytical methods.
"What is quality? Quality is when the customer comes back, not the product." :-)
