Archives: Guidelines

Storage and Distribution, Transport and

WHO TRS 1025 – Annex 7: Good Storage and Distribution Practices for Medical Products (June

Stability & Hold time studies

ICH Q1A (R2): Stability Testing: Stability testing of new drug substances and drug products ICH

Technology Transfer

WHO TRS 1044 – Annex 4: WHO Guidelines on Technology Transfer in Pharmaceutical Manufacturing ISPE:

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

Site Master File (SMF)

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

Shared Facilities / Dedicated Facilities

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

Rounding off, Statistics

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

Quality Risk Management (QRM)

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