Microbiological data deviations result from microbial test results that fall outside the product specification or acceptance criterion established in a drug application, drug master file, official compendia, good manufacturing practice regulations, or internally by the manufacturer. The term “microbial data deviation” is preferred to “out-of-specification” or “out-of-limit result”, as most microbiological tests, especially in a sterile product manufacturing facility, are in-process tests, not finished- product tests that must meet a regulatory-approved specification. This is an area of continued focus for regulatory authorities during inspections and document reviews. However, it is also an area of limited guidance from health authorities.
Attend the 2023 PDA Microbial Data Deviation Investigations Workshop to provide additional information following the 2022 MDDI Conference as well as get both a recap of the newly developed PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry, as well as real world examples that can be used to develop and improve your current approaches and strategies to manage these events.