Microbial data investigations and effective implementation roadmap of Contamination Control Strategy
Microbial data deviations are test results that exceed the established specifications or acceptance criteria in a drug application, drug master file, official compendia, good manufacturing practices, or internally by the manufacturer. This includes, but is not limited to, results generated during utilities monitoring, active principal ingredients, materials, in process control and semifinished product testing as well as during environmental monitoring. The validity of the test results is supported by a documented laboratory and manufacturing investigation. A Contamination Control Strategy (CCS) is a cyclical process designed to prompt the manufacturers to identify and resolve risk. A (CCS) should be implemented across the facility to assess the effectiveness of all control and monitoring measures employed by a company. And this is living across the lifecycle of the product/process within an effective Quality Management System.
This presentation includes a holistic approach for conducting a microbiological investigation. It provides a framework to support the investigation of the root cause of microbial data deviations, focusing on all contributing areas, such as sampling, test methodology, and suitability of the test.
An effective CCS is a key enabler to ensuring Compliance to the revised Annex 1 GMP. The preparation of a CCS is challenging and requires a multi discipline team with full process and scientific knowledge. An effective roadmap planning is needed to ensure an identification and assessment of all key components where Contamination Control applies.
