Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs; USFDA Updates on possible
Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for
USFDA: High Purity Water System; Guide To Inspections Of High Purity Water Systems USFDA Inspection
USFDA: Changes to an Approved NDA or ANDA USFDA: Changes to an Approved NDA or
WHO TRS 1044 – Annex 4: WHO Guidelines on Technology Transfer in Pharmaceutical Manufacturing ISPE:
WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products (June
Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and
ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products ICH
USFDA : Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance
USP Chapter 11: REFERENCE STANDARDS (Access USP) European Pharmacopoeia Chapter 5.12 – Reference Standards (Access
