Warning letters, 483s, Recalls, Import Alerts, Audit observations
ICH: Quality Risk Management – Q9(R1) – Final version – Adopted on 18 January 2023
Regulatory Guidelines on Reserve Samples, Retention Samples, Reference Samples, Retention of Bioavailability and Bioequivalence (BA
USFDA, EMA, ICH Guidelines on Pharmaceutical Development for Medicinal Products, Dosage Forms, Drug Substances (APIs),
EU GMP Annexure 16 Guidance’s, Qualified Person (QP), Batch Release, QP Declaration, Templates EU GMP
ICH Q2(R2): Validation of Analytical Procedures; Final Version; Adopted on 1 November 2023 ICH Q(14):
USFDA – Expiration Dates – Questions and Answers USFDA Inspection Technical Guides: Expiration Dating and
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
WHO TRS 1025 – Annex 4: WHO Good Chromatography Practices EC (European Council) Directive 96/23/EC:
USFDA: Drug Master Files: Guidelines USFDA: Drug Master File (DMF) Templates USFDA: Drug Master Files
