PDA TR 88

Microbial data deviations are 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. This includes, but is not limited to, results generated during environmental and water monitoring as well as pharmaceutical ingredient, in-process, and finished product testing. The validity of the test results is supported by a documented laboratory and manufacturing investigation, where applicable.
The information presented in this technical report was compiled by a team of experts representing both industry microbiologists and regulators and reflects current industry best practices. The membership of personnel from the U.S. Food and Drug Administration (FDA) on the task force does not imply Agency endorsement. Feedback from industry and regulatory professionals was evaluated and incorporated into the technical report to ensure that the suggested methods, terminology, and practices for conducting microbial data deviation investigations reflect sound science and current technological approaches. This technical report is not intended to establish any mandatory or implied standards. Published references supporting the recommendations presented are cited in the text and listed in Section 7.0 References.