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ISO 9001 versus GMP – Part 2

February 14, 2012

Dominic Parry

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.  NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.

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.

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Post a comment
  1. David Reynolds #
    January 16, 2013

    Whilst the comments are true concerning ISO9001, there are a large number of ISO standards thta can be more explicit and detailed than the GMP regulations. Whilst the scope of most of these standards are for the healthcare industry they are generally targeted for medical devices, especially in Europe where there is not regulatory guidance for manufacture (unlike the USA). It is worth looking to see what ISO standards are availble. A number ae still usefull to the pharma industry even if not specifically stated.

    • January 16, 2013

      Yes – good point. This article was specifically about ISO 9001 – but there are of course many other standards that go into enormous details. Keep in touch and adding your opinions – they are most valued.

  2. February 21, 2013

    thanks ,briefe explanation about O 9001 standarda> IS and GMP

  3. Marco-Tobias Kühn #
    August 19, 2013

    ISO 9001 is very general but there are more specific standards, e.g. ISO 13485 for medical devices, ISO 15378 for primary packing for pharmaceutical products.
    The change of the ISO after 1994 is to make it process oriented. The original sence never change as described …

  4. October 10, 2013

    Nice post, I bookmark your blog because I found very good information on your blog, Thanks for sharing
    Quality Services & Training Pvt. Ltd.

  5. October 17, 2013

    Clear explanation about GMP and ISO 9001 Process that impact on the organization.

    ISO Certification

  6. Cathal Watters #
    October 2, 2014

    Great resource to help me with my GMP college course, cheers!

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