This paper from the BioPhorum Commercial Lines of the Future team provides an overview of the future needs of the industry for aseptic manufacture and will inform and assist equipment providers in developing the appropriate technology. It is divided into general and detailed requirements. The general requirements are capability and capacity, and the detailed requirements are decontamination, filling, environmental monitoring, component handling, and connectivity.
URS
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A structured approach for the evaluation, validation and implementation of NAT-based mycoplasma detection methods
Feb 2023 | Deliverable, Deliverables Report, POI - Technology Strategy, Publication, Rapid Methods for Adventitious Agents, Technology Strategy
This paper provides case studies and best practice guidance for validation of an alternative mycoplasma detection assay. It includes an example of completing a user requirement specification (URS) for evaluating an alternative mycoplasma detection assay, validation and implementation. Strategies are also provided to help identify suitable technologies for defined applications. Finally, a framework is given to demonstrate how a validation protocol for an alternative mycoplasma detection assay can be executed to meet the regulatory expectation that the alternative method is equivalent to or better than the current compendial methods.