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Data integrity: an opportunity to improve classical microbiological methods

Posted: 19 October 2020 | | No comments yet

Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.

This issue is exacerbated by the fact that most, if not all, classical microbiological pharmacopoeia chapters were written with little or no consideration of DI. Auditors continue to focus on the subject as an indicator of a company’s quality culture and training to detect DI gaps.

As classic microbiological methods were designed without consideration of DI, they are difficult to align and fully comply with today’s modern expectations. Inefficient quick patches, like the four-eyes principle – where the procedure is performed by two operators instead of one – can be applied, but are only temporary fixes to DI gaps and do not eliminate the long-term potential for continual human error or violation.











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