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| home > epc > summer 2004 > how to implement iso 9001 in a gcp/cro environment |
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European Pharmaceutical Contractor
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The ICH Good Clinical Practice guideline (ICH GCP) defines the requirements for quality in a clinical study. These requirements are focused on the two main objectives of GCP: the protection of rights, integrity and confidentiality of trial subjects; and ensuring the accuracy and credibility of trial data and results. GCP determines which processes and documents must be in place with sponsors, investigators and ethics committees. It is the quality system that has become the worldwide standard for the clinical research environment.
However, GCP does not provide many clues on how to set up these processes, how to manage them and how to ensure that they are efficient and effective. Writing SOPs to ensure that all GCP requirements are being met is an important step, but it is certainly not enough. SOPs are an important part of a quality system, but a collection of SOPs does not equal a quality system.
The ISO 9000 series of quality system standards provide helpful advice on how to deal with those issues. The focus of ISO 9000 is on the structure and management of the organisation and not on its products and services output. When applied to a GCP environment, it offers complementary and very useful guidance on how to implement quality within the organisation. In this article, we will examine how the principles and main chapters of ISO 9001 can be translated and implemented in a clinical research work situation, and what advantages they offer when used in combination with a GCP system.
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