Guidance on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing

How are we supposed to handle microbiological deviations. Is there any useful guidance? The existing OOS Guidance Document of the FDA was not developed and designed for microbiological deviations and is therefore not really useful.

To provide members with recommendations and guidance in this field, the Pharmaceutical Microbiology Working Group started to develop new guidance documents on the handling of microbiological deviations. In January 2018, the first chapter was finalized and will be published on the website of ECA's Pharmaceutical Microbiology Group.

This document provides examples for controlled room requirements (action and alert levels) and serves as a guide for the handling of deviations occurring during microbiological environmental monitoring in facilities manufacturing non-sterile pharmaceutical products.

The new document includes the following content:
1 Purpose
2 Procedures
2.1 Examples of controlled room requirements
2.2 Procedure if the alert level or action level is exceeded
2.2.1 Identification of isolate
2.2.2 Sampling error
2.2.3 Laboratory investigation (Lab error)
2.2.4 Historical data and trending
2.2.5 Re-Sampling
2.2.6 Investigation by production
2.2.7 Affected product batches
2.2.8 Risk assessment for released products
2.2.9 Additional product testing
2.2.10 Release of batches after re-sampling of environmental monitoring
2.2.11 Final decision by QA
3 Appendix
4 References
5 Abbreviations

The document will be presented by the authors at the European Microbiology Conference on 25 and 26 April 2918 in Vienna, Austria. Take advantage of this unique opportunity to receive your copy of this new guidance and to discuss it as well as other interesting microbiological topics with colleagues from industry, laboratory and authority. Moreover, benefit from a pre-conference workshop on Data Integrity in Microbiology on 24 April covering the regulatory requirements and presenting approaches and practical experiences in implementing data integrity strategies in microbiological laboratories.

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