The Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompass all the essential information related to the manufacturing process, quality control release testing, product specifications, stability, and the manufacturing facility with its support utilities. CMC regulatory affairs and compliance serve as a governance process, ensuring that CMC practices adhere to the requirements and expectations set by regulatory agencies, which evolve over time. Consequently, maintaining compliance involves updating all CMC practices accordingly.

For pharmaceutical organizations, adhering to CMC-specific commitments made to regulatory agencies, whether verbal or written, is critical. Failure to do so can lead to non-compliance with manufacturing procedures. Within the EU, the marketing authorization holder and Qualified Person bear responsibility for ensuring that the medicinal product’s manufacturing adheres to the details provided in the CMC section of the approved dossier, as specified in Directive 2001/83/EC.

The consequences of non-compliance can be severe, ranging from rectifying differences under regulatory authority scrutiny to facing fines, withdrawal of marketing authorization, or suspension of product distribution at national or regional levels. Many companies attribute non-compliance issues within their manufacturing organization to a lack of robustness in their change control system, extending from manufacturing quality to regulatory affairs functions.

To prevent non-compliance and its detrimental impact on the company’s reputation, strengthening the change control system and CMC pharma infrastructure is essential. If potential divergence between registered CMC details and manufacturing practices is suspected, a compliance program should be initiated or continued to identify and rectify issues.

Initiating a compliance program requires defining its scope and allocating sufficient resources. This program may encompass a single marketing authorization in one country or extend to include multiple countries and the company’s entire portfolio. Clearly identifying decision-makers, roles, and responsibilities from the outset is crucial, as the compliance program may involve difficult decisions. Inclusion of the quality organization and (EU) Qualified Persons responsible for product release is vital in such initiatives.

Measuring compliance within a CMC pharma may lead to conflicts of interest, as the results can be perceived as a measure of a function’s performance. To ensure impartiality, some companies opt for using an experienced regulatory outsourcing provider for critical project components.

In conclusion, identifying and rectifying regulatory non-compliance within the manufacturing organization often boils down to building robust change control systems. Senior management must align on process change strategies, and implementation teams at the operational level should possess the authority to drive remediation programs to completion. By adopting a proactive approach and robust compliance measures, organizations can safeguard their reputation and maintain regulatory compliance effectively.

Ready to Strengthen Your CMC Compliance and Protect Your Company’s Reputation? Take Action Now and Implement a Robust Change Control System! Contact Us Today to Start Your Compliance Journey.

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