PT - JOURNAL ARTICLE AU - Christopher Phillion AU - Stephen Yang AU - Ren-Yo Forng AU - Tim Cirbo AU - Aileen McMeel AU - Brian Kiler AU - Derek Willison-Parry TI - Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies that Include Leveraging Multi-Site Data to Drive an Efficient Program AID - 10.5731/pdajpst.2018.009662 DP - 2019 Jan 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - pdajpst.2018.009662 4099 - http://journal.pda.org/content/early/2019/11/15/pdajpst.2018.009662.short 4100 - http://journal.pda.org/content/early/2019/11/15/pdajpst.2018.009662.full AB - For manufacturers of both sterile and non-sterile pharmaceuticals alike, there is an expectation that the manufacturing process is performed in an aseptic manner in which the products are provided in a safe, integral, pure, and unadulterated form. As part of that process, cleaning and disinfection are an absolute necessity. While cleaning and disinfection maintain control of microbial contamination preventatively and through corrective action, they do not have specific compendial obligations. The intent of this paper is to provide a general guidance on how to perform cleaning and disinfection efficacy testing. 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.