Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Stratified Sampling – Content Unif

Refer discussions under Questions and Answers on Current Good Manufacturing Practice Regulations | Production and

Qvents
October 11, 2023

Stability & Hold time studies

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

Qvents Team
October 11, 2023

Sterile Manufacturing

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

Qvents
October 11, 2023

Standards (Reference standards, Working

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

Qvents
October 11, 2023

Specifications and Tests

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

Qvents Team
October 11, 2023

Shared Facilities / Dedicated Facilities

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

Qvents
October 11, 2023

Site Master File (SMF)

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

Qvents
October 11, 2023

Reserve Samples / Retention Samples

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

Qvents
October 11, 2023

Rounding off, Statistics

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

Qvents
October 11, 2023

Recalls

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

Qvents
October 11, 2023