This paper has been written to address the compliance challenges of RTRT and the continued compliance with GMP standards. To evaluate these challenges, we have reviewed the current quality guidelines that apply to RTRT and considered the areas and activities that will be impacted by an RTRT process.
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Following A framework for the evaluation, validation and implementation of alternative and rapid microbiological testing methods, BioPhorum will publish case studies on the application of this framework. The first article of this series explores automated colony counting systems and discusses how these systems can reduce or eliminate sources of human error, provide faster and more precise detection of microbial colonies, and allow greater...
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Mar 2022 | POI - Fill Finish
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