Discussion forum for Pharma Quality events, Regulatory Actions

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

Qualified person (QP) and Batch release

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

Qvents
October 11, 2023

Process Validation

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

Qvents
October 11, 2023

Pharmacovigilance

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

Qvents
October 11, 2023

Out of Specifications (OOS)

USFDA: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision MHRA: Out-of-specification

Qvents
October 11, 2023

Nitrosamines

USFDA: Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs; Updated 2/24/21 USFDA Updates

Qvents
October 11, 2023

Manufacturing Date and Expiry Date

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

Qvents
October 11, 2023

GMP Good Manufacturing Practices –

USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs;

Qvents
October 11, 2023

Field Alert Reports (FAR-USFDA); Europe

USFDA Field Alert Reports; USFDA Field Alert Report Submission: Questions and Answers Guidance for Industry;

Qvents
October 11, 2023

Excipients related

Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for

Qvents
October 11, 2023

Data Integrity 1

USFDA Data Integrity and Compliance with Drug CGMP Questions and Answers – USFDA Guidance for

Qvents
October 11, 2023