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04.01.21 -- Auditing Electronic Batch Records For cGMP Status


04.01.21 Auditing Electronic Batch Records For cGMP Status
 
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Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights
Article ....

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03.16.21 -- 11 Critical Steps To Manage Solvents During API Manufacturing


03.16.21 11 Critical Steps To Manage Solvents During API Manufacturing
 
 
Gibco premium peptones are specifically created for bioprocessing to achieve a higher level of quality and limited variability. The result can improve performance and speed-to-market for your next monoclonal antibody (mAb) blockbuster. Considering peptones but unsure where to start? Learn about smaller-sized Starter Paks the easiest way to assess the variety of peptones offered and to identify the ideal supplements for your process.
Featured Editorial
By Grant Mordue, Pro-Active GMP Consulting Ltd.
To reduce costs and provide flexibility, manufacturers and distributors use multipurpose tankers for organic solvents for the manufacturing of APIs and associated intermediates. This article explores the risks and 11 mitigation options available to API manufacturers. ....

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