Archives: Guidelines

Controlled Correspondence / Scientific A

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

Computer systems validation (CSV), Elect

USFDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application USFDA

Cleaning Validation

APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient

Clean Rooms & HVAC Systems

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

API DMF (Drug Master File)

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