Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Reserve Samples / Retention Samples

USFDA: 211.170 Reserve samples. USFDA – Retention of Bioavailability and Bioequivalence Testing Samples USFDA: Handling

Quality by Design (QbD) Design of Experi

ICH Q8(R2): Pharmaceutical Development (For dosage forms) ICH Q8, Q9 and Q10: Questions & Answers

Qualified person (QP) and Batch release

Annex 16: Certification by a Qualified Person and Batch Release (EudraLex – Volume 4 –

Process Validation

USFDA: Process Validation: General Principles and Practices – Guidance for Industry European Medicines Agency (EMA)

Pharmacovigilance

USFDA Guidance for Industry: E2E Pharmacovigilance Planning USFDA: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment USFDA

Method Validations

ICH Q2(R2): Validation of Analytical Procedures; Final Version; Adopted on 1 November 2023 ICH Q(14):

Manufacturing Date and Expiry Date

USFDA – Expiration Dates – Questions and Answers USFDA Inspection Technical Guides: Expiration Dating and

Cleaning Validation

APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient

Clean Rooms & HVAC Systems

USFDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance

Chromatography Practices

WHO TRS 1025 – Annex 4: WHO Good Chromatography Practices EC (European Council) Directive 96/23/EC: