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| home > pmps > summer 2004 > early experience of 'the clinical trials directive' from a contract manufacturing company |
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Pharmaceutical Manufacturing and Packing Sourcer
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The European Union Clinical Trials Directive 2001/20/EC became effective on 1st May 2004 and has a direct effect on the responsibilities and operations of contract manufacturers (1). This article describes the Directive's early impact on a typical contract house operating in small-scale pharmaceutical development and manufacture. It will describe the experience of preparing for implementation, note the impact of the Directive on day-to-day operation, identify communications needs and comment on benefits and issues typical to a contract service.
Preparation
Awareness and Training
Specific in-house preparations for the Directive started in January 2003 with the attendance of site Qualified Persons (QPs) at courses run by their respective professional bodies, study periods and extensive internal discussions on policy and technical detail. It was clear that the detailed interpretation of the legislation was still open to discussion and expansion. There was particular difficulty in identifying the parts of Good Clinical Practice (GCP) compliance requirements that were relevant to the operation. These were identified as:
The possible GCP inspection of the manufacturing facility
The need for awareness of relevant components of the Investigator Brochure (for instance chemical, pharmaceutical and pharmacokinetic properties)
Awareness of the needs of the supply chain to assure continuing product integrity
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