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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
An effective monitoring system provides assurance of
the continued capability of processes and controls to
produce a product of desired quality and to identify
areas for continual improvement.
The pharmaceutical company should have a system
3.2.2 CORRECTIVE for implementing corrective actions and preventive
ACTION AND actions resulting from the investigation of
PREVENTIVE complaints, product rejections, non-conformances,
ACTION (CAPA) recalls, deviations, audits, regulatory inspections
SYSTEM
and findings, and trends from process performance
and product quality monitoring...
....The change management system ensures
continual improvement is undertaken in a timely and
effective manner. It should provide a high degree of
3.2.3 CHANGE
MANAGEMENT assurance there are no unintended consequences of
SYSTEM the change...
(q) Quality risk management should be utilized to
evaluate proposed changes...
Management responsibility
The PQS places additional emphasis on the critical role management plays in
ensuring product quality, compliance and effective process controls.
Management provides leadership, and approves processes, systems and
resources. They also take ultimate responsibility for the effectiveness of the QA.
GMP and QC processes and procedures.
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