Empowering Customer Success Through Assurance Of Single-Use Supply
By Mukta Acharya, General Manager, Flexible and Rigid Strategic Containment Business, Bioprocess Division, Thermo Fisher Scientific
Single-use technology (SUT) has come a long way in the last 20 years. Early on, biopharma and biotech embraced it primarily in process development and early-phase clinical trials but in recent years, the industry has seen higher adoption of SUT in cGMP manufacturing, due to the many benefits it offers, such as shorter turnover time as well reduced capital investment in equipment. The flexibility of SUT also allows for a more fit-for-purpose product that meets the needs of each manufacturer’s unique process.
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