Warning letters, 483s, Recalls, Import Alerts, Audit observations
Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for
USFDA Data Integrity and Compliance with Drug CGMP Questions and Answers – USFDA Guidance for
USFDA Controlled Correspondence Related to Generic Drug Development USFDA Guidance Document – Controlled Correspondence Related
USFDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application USFDA
APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient
USFDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance
USFDA: Drug Master Files: Guidelines USFDA: Drug Master File (DMF) Templates USFDA: Drug Master Files
