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CMC Regulatory Affairs

Introduction

Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body of information that defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance. CMC regulatory compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. Since such requirements and expectations change with time, a function of CMC regulatory compliance is to ensure that all CMC practices are updated accordingly.

CMC Regulatory compliance ensures that, if the pharmaceutical organization has made any CMC-specific commitment to regulatory agencies, either verbally or in writing, such CMC practices are carried out.

If a marketing authorization holder has a product which is not manufactured, packed, tested or as stable as described in the information supplied to the relevant national authority, then the MA is considered to be in non-compliance with manufacturing procedure.

RESPONSIBILITIES OF CMC PERSON

  • Expert Strategic regulatory support for product development issues by considering regulatory authority requirements and standards
  • Regulatory support for CMC compliance throughout product life-cycle
  • Expert Pharma Regulatory Affairs professional for scientific review of submission documents, compilation and finalization like administrative quality summary (module 2), CMC quality – drug product, drug substance and regional information (module 3)
  • Support to identify the gaps (gap analysis) in dossier as per Agency requirements
  • Precise Response / justification to Agency queries like Filling Review Comments (FRC), Information Request (IR), Discipline Review Letter (DRL), Complete Response (CR),