1. ICH Q11: development and manufacture of drug substances (chemical entities and biotechnological/biological entities) – scientific guideline
2. ICH Q8 (R2) pharmaceutical development – scientific guideline
3. EU guidelines for good manufacturing practice for medicinal products for human and veterinary use, Volume 4, Annex 15: qualification and validation
4. US FDA guidance for industry process validation: general principles and practices
5. ICH Q9 (R1) quality risk management-guidance for industry