Archives: Guidelines

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

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

Out of Specifications (OOS)

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

Nitrosamines

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

Manufacturing Date and Expiry Date

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

GMP Good Manufacturing Practices –

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

Field Alert Reports (FAR-USFDA); Europe

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