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A lot has been said about ISO 9001 in the pharmaceutical industry.  This article tries to compare the two fairly.  You should read Part 1 first to get some idea of the differences.  One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing.  GMP is a product quality standard, with a focus on getting the right quality product to the only customer of GMP – the patient.  ISO 9001 on the other hand is more about running a whole business, a goal of which will be getting product of the right quality – but other aims are important too.  Whilst GMP focuses on Production and Quality Control – ISO focuses on the all departments and processes of an organisation.

It is true that GMP has much more depth when it comes to focusing on product quality.  It can do this because it is specifically written for pharmaceutical manufacturing.  ISO cannot really do this because it is a generic standard for all types of organisations.  Where ISO is stronger than GMP is in the areas of Top Management responsibilities for their quality system, continual improvement of all processes and a focus on all customers, both internal customers and external customers.  If it is used correctly ISO encourages the organisation to monitor, review and improve the quality system in order to drive improvements in all areas.

ISO was looked at by the pharmaceutical industry in general in the mid-1990’s.  At the time the version of ISO (the 1994 version) was a product quality standard (like GMP).  This is not really the case now, and it is more a standard for Top Management to be able to link the quality system with the needs and priorities of the business.  From Part 1 of this article you can see how there are clearly areas of ISO that GMP does not cover.  Likewise there are areas of GMP where much more depth is provided.  What is worthwhile considering that it is not either ISO or GMP – it can be both.  Your quality system can continue to operate using the strength and depth of GMP, but can evolve to bring in ideas that are covered much better in ISO.  This is very much in line with current pharmaceutical quality thinking via ICH Q10 and the FDA’s quality System Model.

What are your thoughts on this?  Please make a comment.

THIS ARTICLE WAS ORIGINALLY PUBLISHED IN 2012 AND HAS BEEN REVIEWED AND UPDATED IN OCTOBER 2022.

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

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