ICH Q10 Pharmaceutical Quality System and Q11 Development and Manufacture of Drug Substances Guideline

Pharmaceutical Quality System

Q10- Pharmaceutical Quality System.

Q8/9/10 Q&As (R5) Q8/Q9/Q10- Implementation.

Development and manufacture of Drug Substances

Q11- Development and Manufacture of Drug Substance (Chemical Entities and Biotechnological/ Biological Entities).

Q11 Q&As- Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances.