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European Biopharmaceutical Review

Quality Control

Quality control is too often perceived simply as the last phase in the many stages of product manufacture; a box ticking exercise to check that what has been made meets the required specification. However, quality control should be considered as a key driver for increasing product value. In a multiproduct biopharmaceutical facility that manufactures products using a wide range of technology platforms, efficient, effective and appropriate quality control is fundamental to business success.

Effective quality control begins well before a product or project even enters the manufacturing facility; ensuring the quality of the manufacturing environment, utilities and cleaning are key to determining project success or failure. The main aim of many quality groups has often been to develop the necessary systems to obtain a license for a facility or product...

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Kate Westwell is a QC Microbiologist at Eden Biodesign with eight years’ experience in microbiological techniques and industry practices. She previously lead a Microbiology Department in a large pharmaceutical company ensuring strict regulatory and cGMP compliance (Chiron). Experienced in environmental monitoring, product and utilities testing, assay and equipment validation, as well as provision of technical support and microbiological guidance.

Gina Wenham is an Analytical Development Manager at Eden Biodesign Ltd. She is an experienced technical manager with 19 years’ pharmaceutical experience. She has held key positions in the pharmaceutical industry as a technical manager of both development and quality control groups (ML Laboratories), managed the development and validation of QC tests and procedures for a range of the companies products from clinical trials materials through to licensed products. She has also successfully prepared laboratories for MHRA, FDA and BSI accreditation.

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Kate Westwell
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Gina Wenham
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