Archives: Guidelines

Sterile Manufacturing

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

Standards (Reference standards, Working

USP Chapter 11: REFERENCE STANDARDS (Access USP) European Pharmacopoeia Chapter 5.12 – Reference Standards (Access

Specifications and Tests

ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances And New Drug

Shared Facilities / Dedicated Facilities

USFDA 21 CFR 211.42: Design and construction features.(Pencillins require dedicated facilities) USFDA Guidance: Non-Penicillin Beta-Lactam

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 EU GMP

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