The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Further Process Deviation Management is about capturing, analyzing and managing data and improvement actions related to process deviations. Process deviations can be about operations, HSE, and quality. The essence is to understand which controls or barriers have failed or proven to be reliable – and why this is the case.
At a minimum, GMP requires written procedures for the following:
Additionally, while there are various GMP standards, each of them, whether ICH, the FDA, or the EU GMP standard, requires the documentation of any deviation.
An efficient deviation handling system should implement a mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations. The key principles are: build on ICH E3 Q&A R1 of "Protocol Deviation"
For "important protocol deviations" as a subset of protocol deviations which can significantly impact key study data, ICH E6 R2 must be incorporated.
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The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company.
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Read MoreThe management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.
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Read MorePost implementation training services relate often to process changes. With training services implementations are ready for success. The Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.
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