Remedial Actions
A remedial action, in this context, should be defined as the process of providing a change to non-conforming products, manufacturing processes, and company policies in order to properly address those deficiencies. This action (or actions) should be executed under a comprehensive plan that will later confirm effectiveness. Remediation Plans that are well planned and executed should effectively bring products and company to acceptable levels of GMP compliance.
The sooner these remediation plans are designed, and actions executed, the better chance your company will have to remain open and minimize losses, even if a recall operation is involved.
The best approach to take is by organizing lines of actions in individual CAPA investigations. A comprehensive CAPA investigation will identify and investigate existing and potential products, processes and quality problems. This approach will serve to your Quality Unit to initiate the investigation(s) and put in motion a set of actions to eliminate nonconformities on systems, processes or products, and to later verify their non-recurrence.
Some of the services that our group provide in this Category are:
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Response to 483 and Warning Letters
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Response to Consent Decrees
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Continuous Interaction with US FDA and/or other Global or Local Regulatory Agencies
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Development of Planned and Unplanned Deviations
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Remediation Project Management
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Complaint Investigations
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Recall Response
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CAPA Investigations
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Root Cause Analyses to determine root cause using Quality Engineering tools such as Ishikawa “Fish bone” Diagram, IS/IS NOT, 5-Why, Change Point Analysis, Contradiction Matrix, Design of Experiments, etc. as appropriate.
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Qualified Personnel Recruitment
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Direct Supervision and Continuous Assistance
