Warning letters, 483s, Recalls, Import Alerts, Audit observations
Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference
USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs;
USFDA Field Alert Reports; USFDA Field Alert Report Submission: Questions and Answers Guidance for Industry;
Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for
Qvents compilation of regulatory guidelines on Data Integrity : FDA guidance for design, operation, and
USFDA Controlled Correspondence Related to Generic Drug Development USFDA Guidance Document – Controlled Correspondence Related
USFDA: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision MHRA: Out-of-specification
Qvents compilation of regulatory guidance’s on Computer System Validation, Electronic Data Review from USFDA, EMA,
