Archives: Guidelines

Recalls

USFDA on Recall: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C :

Quality Risk Management (QRM)

ICH: Quality Risk Management – Q9(R1) – Final version – Adopted on 18 January 2023

Quality by Design (QbD) Design of Experi

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

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

Out of Specifications (OOS)

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

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

Field Alert Reports (FAR-USFDA); Europe

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

Data Integrity

Qvents compilation of regulatory guidelines on Data Integrity : FDA guidance for design, operation, and