Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
| Autor: | Ren-Yo Forng, Tim Cirbo, Derek Willison-Parry, Christopher Phillion, Brian Kiler, Aileen Mcmeel, Stephen Yang |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Process (engineering)
Computer science Manufacturing process media_common.quotation_subject Best practice Control (management) Multi site Pharmaceutical Science 010501 environmental sciences 01 natural sciences Disinfection 03 medical and health sciences 0302 clinical medicine Risk analysis (engineering) Action (philosophy) Leverage (statistics) Technology Pharmaceutical Quality (business) 030212 general & internal medicine Drug Contamination 0105 earth and related environmental sciences media_common Disinfectants Environmental Monitoring |
| Zdroj: | PDA journal of pharmaceutical science and technology. 74(2) |
| ISSN: | 1948-2124 |
| Popis: | For manufacturers of both sterile and nonsterile pharmaceuticals, there is an expectation that the manufacturing process is performed in a manner that prevents extraneous contamination so that the products are provided in a safe, integral, pure, and unadulterated form. As part of that process, cleaning and disinfection are an absolute necessity. Although cleaning and disinfection support control of microbial contamination through preventive and corrective action, specific compendia methods do not currently exist. The intent of this paper is to provide a general guidance on how to perform disinfectant efficacy validation and implementation. This includes how to make sure the concepts are understood, how to interpret facility data and utilize it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. This paper represents the thoughts and best practices of the authoring team and their respective companies and provides an efficient way to qualify disinfectants without impacting the quality of the study. If you choose to follow the recommendations in this paper, you must ensure that the appropriate rationale is sound and the scientific data is documented. It is the belief of the authoring team that only then will this approach meet regulatory requirements. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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