Validation
- EU GMP Annex 15 – Qualification and Validation
- EU GMP Annex 11 – Computer Systems
- ASTM E2500
- ISPE
- GAMP 5
- FDA 21CFR Parts 210 , 211
- FDA 21CFR Part 11 – Electronic Records and Signatures
- EU GMP Annex 1 : Manufacture of Sterile Medicinal Products
Pharmaceutical Development and Commercialisation
- EudraLex Volume 4, GMP Part II – Basic Requirements for Active Substances used as Starting Materials
- FDA Guidance for industry: Drug Substance Chemistry, Manufacturing, and Controls Information (Contains Non-Binding Recommendations)
- ICH Q7 -GMP for Active Pharmaceutical Ingredients
- ICH Q8 – Pharmaceutical Development
- ICH Q9 – Quality Risk Management
- ICH Q11 Development and Manufacture of Drug Substances
- ICH Q1 A (R2) Stability Testing of new Drug Substances and Products
- ICH Q3A : Specification for degradation Products
- ICH Q6A , Q6B : Specification, which is a list of tests, reference to analytical procedures, and proposed acceptance criteria
- WHO Annex 1 – Guidelines for assuring quality and non-clinical safety evaluation of DNA Vaccines