Warning letters, 483s, Recalls, Import Alerts, Audit observations
Annex 16: Certification by a Qualified Person and Batch Release (EudraLex – Volume 4 –
USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs;
Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference
USFDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015) USFDA: Scientific Considerations
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
