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 NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.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