Archives: Guidelines

Sampling, AQL

WHO TRS 929 – Annex 4: WHO Guidelines for Sampling of Pharmaceutical Products and Related

Site Master File (SMF)

EMA – EU Site Master File (EudraLex – Volume 4 – Good Manufacturing Practice (GMP)

Reserve Samples / Retention Samples

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

Rounding off, Statistics

Refer USP General Notices: USP General Notices: Significant Figures and Tolerances USP General Notices &

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

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