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 - 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 (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

	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)

	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 July 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)

	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

	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