Archives: Guidelines

Biosimilars / Biologics

USFDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015) USFDA: Scientific Considerations

API DMF (Drug Master File)

USFDA: Drug Master Files: Guidelines USFDA: Drug Master File (DMF) Templates USFDA: Drug Master Files

Water system

USFDA: High Purity Water System; Guide To Inspections Of High Purity Water Systems USFDA Inspection

Variations and Changes – NDAs, ANDAs,

USFDA: Changes to an Approved NDA or ANDA USFDA: Changes to an Approved NDA or

Stratified Sampling – Content Unif

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and

Sampling, AQL

WHO TRS 929 – Annex 4: WHO Guidelines for Sampling of Pharmaceutical Products and Related

Recalls

USFDA on Recall: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C :

Nitrosamines

USFDA: Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs; USFDA Updates on possible

Inspections (GMP, Others)

Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference

GMP Good Manufacturing Practices –

USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs;