GMP Good Manufacturing Practices – Medicinal Products and Active Pharmaceutical Ingredients (APIs) – Qvents

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Updated on January 30, 2025

Updated on January 30, 2025

USFDA 21CFR PART 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General
USFDA 21 CFR PART 211—Current Good Manufacturing Practice For Finished Pharmaceuticals
USFDA: Q&A on CGMP Requirements
USFDA Q&A: Questions and Answers on Current Good Manufacturing Practice Requirements – Control of Components and Drug Product Containers and Closures
USFDA: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
USFDA: FDA advises drug manufacturers that Burkholderia cepacia complex (BCC) poses a contamination risk in non-sterile, water-based drug products
WHO TRS 986 – Annex 2: WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles
WHO TRS 957 – Annex 2: WHO Good Manufacturing Practices fFor Active Pharmaceutical Ingredients (APIs – Bulk Drug Substances)
WHO TRS 957 – Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances
WHO: Quality assurance of pharmaceuticals: A compendium of guidelines and related materials; Tenth Edition : Volume 2 Good manufacturing practices and inspection
Europe: EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
- EudraLex Introduction
- EudraLex – Part I – Basic Requirements for Medicinal Products
- EudraLex – Part II – Basic Requirements for Active Substances used as Starting Materials
- EudraLex – Part III – GMP related documents
- EudraLex – Annexes
- EudraLex – Guidance On Good Manufacturing Practice and Good Distribution Practice: Questions And Answers
- EudraLex: Other documents related to GMP and GDP
- EMA: Guideline on manufacture of the finished dosage form (EMA/CHMP/QWP/245074/2015)
- PIC/S: Guide To Good Manufacturing Practice for Medicinal Products
  - PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products)
  - PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients)
  - PIC/S GMP Guide To Good Manufacturing Practice for Medicinal Products ANNEXES
  - PIC/S: Remote Assessments
  - PIC/S: Remote Assessments-Aide-Memoire
ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q7A – Q&A (ICH) & Q&A presentation
APIC – GMPs for APIs – How to do – Interpretation of ICH Q7 Guide
MHRA (UK): Volume 4 of the rules governing medicinal products in the EU
TGA (Australia): PE009, the PIC/S guide to GMP for medicinal products; TGA interpretation and expectations for demonstrating compliance
Health Canada: Good manufacturing practices guide for drug products (GUI-0001)
South Africa- SA Guide To Good Manufacturing Practice for Medicines (SAHPRA); SAPHRA Guidelines Page
India DCGI / CDSCO: Revised Schedule M (Gazette Notification December 2023)

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