Reserve Samples / Retention Samples
USFDA: 211.170 Reserve samples. USFDA – Retention of Bioavailability and Bioequivalence Testing Samples USFDA: Handling
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA: 211.170 Reserve samples. USFDA – Retention of Bioavailability and Bioequivalence Testing Samples USFDA: Handling
ICH Q8(R2): Pharmaceutical Development (For dosage forms) ICH Q8, Q9 and Q10: Questions & Answers
Annex 16: Certification by a Qualified Person and Batch Release (EudraLex – Volume 4 –
USFDA: Process Validation: General Principles and Practices – Guidance for Industry European Medicines Agency (EMA)
USFDA Guidance for Industry: E2E Pharmacovigilance Planning USFDA: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment USFDA
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: