GMP Publications

FDA cGMP Guide - Paperback

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

Price*: EUR 19.26,-

EU Guidelines to Good Manufacturing Practice (15th Edition of September 2022)

• Paperback in the handy format 11.5 x 15 cm
• GMP Guide in English
• The 15th edition contains the new Annex 1 and 21

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.

Price*: EUR 37.45,-

ECA Good Practice Guide - GMP Matrix (Version 23 of March 2023)

• 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.

Changes in the 23rd Edition:
New Annex 1 (coming into operation on 25 August 2023)
New Annex 21 (in operation since 21 August 2022)

"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 23 of March 2023)

Price*: EUR 159.43,-

ICH Q7 GMP for APIs & How to do Guide

with a Side-by-Side comparison and APIC's How-to-do Document
Version 16, update of November 2022

• 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)

Price*: EUR 52.43,-

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

• 4th edition, October 2022
• 265 pages
• Original English version plus the official German translation

Price*: EUR 26.75,-

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