This paper describes a systematic nine-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests which can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests. Two case studies are presented to illustrate the validation and implementation approach, including statistical methods.
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Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation
Jun 2022 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Technology Strategy, Publication, Technology Strategy
This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.