Cleaning and disinfection are crucial during the drug manufacturing process. However, while these tasks support the control of microbial contamination through preventive and corrective actions, specific compendia methods do not exist – yet cleaning and disinfection is now a regulatory requirement. This is why BioPhorum’s Microbial Control Workstream has published Disinfectant Efficacy: Understanding the Expectations and How to Design Effective...
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Microbial control: Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
May 2020 | Drug Substance
This paper provides general guidance on how to perform disinfectant efficacy validation and implementation. It includes how to ensure the concepts of disinfectant efficacy are understood, how to interpret facility data and use it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. It also details an efficient way to qualify disinfectants without impacting the quality of the study. The recommended program could be more robust than any individual approach developed in any one site.
As regulators now require thorough validation studies, the paper is not about why you need to do disinfectant efficacy, but how you do it so you can meet that regulatory challenge for study data and will help build a business case for change.