Archives: Guidelines

Clean Rooms & HVAC Systems

USFDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance

Chromatography Practices

WHO TRS 1025 – Annex 4: WHO Good Chromatography Practices EC (European Council) Directive 96/23/EC:

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