Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The guidelines page guides you to important GMP and Regulatory guidelines; provides links to published final and draft guidelines, discussion papers. The page also provides links to guidance and papers by expert bodies and technology platforms like ISPE, PICS, APIC, USP.
Most relevant guidelines and papers are collated subject wise to help users quickly navigate saving trouble of sifting through hundreds of links a typical search throws up
APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient Plants
TGA: Cleaning Validation – A regulatory perspective (Presentation)
WHO TRS 1033 – Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
USFDA PART 11 – Electronic Records; Electronic Signatures; ECFR – 21 Part 11
EC EudraLex (Europe): Annex 11: Computerised Systems – Guidance