‍Abstract: A key foundation to Good Manufacturing Practice, is the execution and routine review of a robust environmental monitoring program. This takes the form of collecting environmental samples from surfaces, personnel and the cleanroom air, whether that be active or passive sampling; these samples are collective on nutrient agar plates. The plates are incubated and then reviewed by microbiologists to assess for the presence/absence or quantity of growth. Data is trended in compliance with the regulatory expectations and assessment of the level of control of the environment is executed prior to batch review.

Regulators have become increasingly interested in Data Integrity across the whole pharmaceutical supply chain, and the microbiology laboratory is not without challenge. The raw data is reported from the agar plate, typically into computerised systems, second checking of results has become common place, however there are questions over the value of contemporaneous second checks - defining the time frame required to execute the second check is important, as additional proliferation can occur, but also the subjective nature of microbiology means that one technician's report of 2 CFU could be another technician's report of 3 CFU.

The availability of automated, computerised plate counting technology has increased in recent years, and there are benefits that can be realised, from enhancing process efficiency, reducing subjectivity, and providing an auditable data trail to the original reported result.‍

White Paper

Date: August 2023

‍Authors: Guest, M. and Giglio, S.

‍Citation: Guest, M. and Giglio, S. 2023. Data Integrity Challenges in the  Pharmaceutical Microbiology Laboratory, Considerations for Current State and  the Application of Technology to Mitigate Risk. White Paper. Aug 23.