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CONTEC CLEANROOM WEBINAR

IMPACT OF THE NEW EU GMP ANNEX 1 ON CLEANING AND DISINFECTION

PREVIOUSLY RECORDED ON MAY 9, 2023

 

Annex 1 was produced by the European Commission via a GMP/GDP working group. The 16-page document increased to a 58-page documents. More than 300 clauses increase from 100 in the 2008 document. Many clauses have been expanded on and additional topics such as single-use technologies, aseptic operator qualifications, application of quality risk, disinfection qualification for cleanroom surfaces, process water systems, other utilities and closed manufacturing systems. 

Contamination Control Strategy

"A contamination control strategy (CCS) should be implemented across the facility in order to define all the critical control points and assess the effectiveness of all the controls (design, procedural, technical and organisational), and monitoring measures employed to manage risks to medicinal product quality and safety." 

Webinar Resources

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Webinar Speakers

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Neil Simpson

Technical Services Manager EMEA and R&D Manager EMEA

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Karen Rossington

Marketing Manager EMEA

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