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
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EU Guidelines to Good Manufacturing Practice (15th Edition of September 2022)
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 |
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ECA Good Practice Guide - GMP Matrix (Version 23 of March 2023)
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) |
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ICH Q7 GMP for APIs & How to do Guidewith a Side-by-Side comparison and APIC's How-to-do Document
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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
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ECA/PQG GuideThe 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.
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Purchase the guide directly on pqg.org |
*All prices plus postage, packing, and VAT (if applicable)