by Specifications
Q6A- Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.
Q6B- Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products.
Q6(R1) EWG- Revision of the Specifications Guidelines.
Good Manufacturing Practice
Q7- Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
Q7 Q&As- Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
