For my CMC and QA colleagues, the open access article published in The AAPS Journal reviews the activity and findings of the FDA CDER division's pilot program that evaluated companies' quality systems maturity (i.e., compliance with Current Good Manufacturing Practices (CGMP)). As noted in the article, over an 18month period, contractors were used to assess companies against a standard assessment tool to determine:
(i) the level of integration of the quality sys- tem and quality objectives with business and manufacturing operations at an establishment,
(ii) the agility of an estab- lishment in responding to unexpected changes (e.g., supply chain disruptions, demand surges, deviations, natural disas- ters), and
(iii) the resilience of an establishment’s business and production processes.
The outcomes are an interesting read (e.g., the time limits for people to respond were not commensurate with the required details, some questions are best answered by management, while others should be answered by those performing the activities.
Based on the success of the pilot, the assessment tool and process are being refined and will continue to be used.
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