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.
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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)