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.
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