Archives: Guidelines

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

Field Alert Reports (FAR-USFDA); Europe

USFDA Field Alert Reports; USFDA Field Alert Report Submission: Questions and Answers Guidance for Industry;

Excipients related

Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for

Data Integrity

Qvents compilation of regulatory guidelines on Data Integrity : FDA guidance for design, operation, and

Controlled Correspondence / Scientific A

USFDA Controlled Correspondence Related to Generic Drug Development USFDA Guidance Document – Controlled Correspondence Related