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Pharmaceutical Manufacturing and Packing Sourcer

Knowledge Sharing in the Clinical Trials Industry - Annex 13

Let us start with the core functions provided by BlisTech UK.

BlisTech Clinical Trial Packaging Ltd's primary function is to provide a comprehensive clinical trial packaging service, providing primary and secondary packaging in a variety of presentations. BlisTech also provide storage, distribution and have two qualified persons (QPs) available for batch release under 75/319/EEC (2001/183/EEC). We also package and provide QP release for commercial products.

In our recent interview with Joseph Saccamono (PMPS Spring 2003) we talked about the aspect of technical knowledge sharing. How has that changed the demands of the European pharmaceutical companies?

Annex 13 has been the classic case where technical knowledge sharing has been crucial. The pharma business has had to wake up to the new GMP requirements to ensure they will be able to initiate and/or continue their clinical trials in May 2004. BlisTech has been sharing information in preparation for QP certification of batches for IMPs in 2004 with new and existing clients, as and when necessary. BlisTech have also employed two QPs to ensure their clients' needs will be met and will be applying for the new IMP Licence when the application forms are released by the MHRA.


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PMPS talks to Jill Warr, Quality Manager and QP at BlisTech UK

Jill Warr graduated with a BSC (Hons) in Combined Science and later obtained a PGDIPS, both from Brighton University, UK. Under permanent transition Jill became eligible for nomination as a QP under the provisions of Directive 75/319/EEC and 81/851/EEC. She became Operational Quality Manger and QP for GlaxoWellcome and GlaxoSmithKline, Dartford UK in 1996 before joining BlisTech UK as Quality Manager and QP in May 2003. Previous experience within the pharmaceutical industry includes formulation development with sterile, solid dose, liquid and cream pharmaceutical formulations, packaging technology and clinical trial packaging.

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