Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs;
Qvents compiled list of regulatory guidelines on GMP inspections from different agencies – USFDA, EMA, EDQM, WHO, PIC-S. Quick reference
Guidance’s and References for setting Specifications, Test methods, Acceptance criteria for Drug products (Formulations, Dosage
EU: Principles of Good Distribution Practice for active substances for medicinal products for human and
ICH Q3E : GUIDELINE FOR EXTRACTABLES AND LEACHABLES EMA: Overview of comments received on ICH
USFDA: Process Validation: General Principles and Practices – Guidance for Industry European Medicines Agency (EMA)
USFDA: 21 CFR PART 174—Indirect Food Additives: General USFDA: 21 CFR PART 175: indirect Food
USFDA: 21 CFR 211 Subpart E: Control of Components and Drug Product Containers and Closures
USFDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015) USFDA: Considerations in
USFDA: Inspection of Injectable Products for Visible Particulates IPA: Visual Inspection of Sterile Products (Best
