Abweichungen im mikrobiologischen Monitoring: Bewertung und Maßnahmen zur Qualitätssicherung
Birgit Schunke und Dr. Michael Jahnke
Haupt Pharma Wülfing GmbH, Gronau
Deviations in Microbiological Monitoring: Evaluation and Measures for Quality Assurance
While deviations of analytical results defined as “Out of Specification (OOS)” are sufficiently described and commented in the literature and generally accepted framework is available for identification of root cause, evaluation and processing, it appears that structured and formalized framework for evaluation of violation of alarm and action levels in microbiological monitoring is needed. In this article, deviations in microbiological monitoring are described and possible measures for structured clarification of the root cause and identification of corrective measures and quality assurance are provided. In addition, proposals for standardized procedures are described and responsibilities defined for the implementation of corrective and preventive measures together with the associated documentation.
pharmind 2011, Nr. 2, Seite 354