GMP Publications

Important: ECA Members are entitled to purchase the GMP publications linked below at a discount of 35%. In order to receive the discounted price, please check the ECA Members Area to find the ECA Promotion Code which you will have to enter when you purchase at amazon.

FDA cGMP Guide

FDA cGMP Guide - Paperback

  • Paperback in the handy format 11.5 x 15 cm, 40 pages
  • 21 CFR 210/211 cGMP Guide in English


     
 EU Guidelines to Good Manufacturing Practice

EU Guidelines to Good Manufacturing Practice (14th Edition of November 2018)

  • Paperback in the handy format 11.5 x 15 cm
  • GMP Guide in English
  • 14th Edition includes the new Annex 2 & 17
Part 1 – Medicinal Products
Part 2 – Active Pharmaceutical Ingredients, incl. Annexes 1-19
Part 3 – Explanatory Notes on the preparation of a Site Master File | Quality Risk Management (ICH Q9) | Pharmaceutical Quality System (ICH Q10) | Internationally harmonised requirements for batch certification | Template for the „written confirmation“ for active substances exported to the EU... | Guideline on setting health based exposure limits for use in Risk identification | Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
Part 4 - Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products of 22 Nov 2017


     
 ECA Good Practice Guide

ECA Good Practice Guide - GMP Matrix (Version 22 of July 2018)

  • FDA cGMP Guide
  • EU GMP Guide Part I, II, III and IV incl. all Annexes
  • ISO 9001 Quality Management Systems
In addition, the Good Practice Guide contains a ISO 9001/ICH10 Matrix.
In total, the Guide has 681 pages.

NEW:
Annex 2 (in operation since 26 June 2018)
Annex 17 (coming into operation on 26 December 2018)
Template IMP Batch Certification (Part III supplement)

"FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap"

The ECA Good Practice Guide is a comprehensive juxtaposition containing the requirements laid down in FDA's cGMP Guide, the EU GMP Guide and ISO 9001.

ECA Good Practice Guide - GMP Matrix (Version 22 of July 2018)


     
 CH Q7 GMP for APIs & How to do Guide

ICH Q7 GMP for APIs & How to do Guide

with a Side-by-Side comparison and APIC's How-to-do Document
Version 10, update of March 2018

  • Paperback in the handy format 15 x 11,5 cm
  • Complete text of ICH Q7 GMP for APIs and comparison of the interpretation by the Active Pharmaceutical Ingredients Committee (APIC)


     
 Guidelines on Good Distribution Practice

Guidelines of 5 November 2013 on Good Distribution Practice (GDP) of medicinal products for human use (Text with EEA relevance) (2013/C 343/01)

Paperback in the handy format 11,5 x 15 cm

  • 95 pages
  • Original English version plus the official German translation


     
ECA/PQG Guide

ECA/PQG Guide

The Pharmaceutical Quality Group's Monograph No. 4 on Good distribution practice has been created in collaboration with the ECA Foundation. It is based on the European Commission Guidelines on Good Distribution Practice of 2013, providing a sound basis for the implementation and maintenance of a GDP quality system.

  • Edition published in 2018
  • Note: GDP Association Members receive a 30% discount when buying the guide on pqg.org
    Visit the GDP Association's website to get the code or find out more on how to become a member.
Purchase the guide directly on pqg.org

 

*All prices plus postage, packing, and VAT (if applicable)

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK