T-32: CMC Outsourcing Through Contract Manufacturing Organization (CMO): Opportunities, Risks and Mitigation

Poster Presenter

Rajan Thumar

Consultant II, Regulatory Affairs
Syner-G Pharma Consulting, LLC
United States

Objectives

Pharmaceutical companies are increasingly turning towards CMOs for their development and commercial manufacturing needs. The objective of this poster is to study the trend of regulatory and quality issues from different geographic locations and how to mitigate the risks when choosing CMOs.

Method

FDA Warning Letters issued to CMOs were examined to identify major issues and common trends, particularly with comparison of issues and trends for US, China, India, and EU.

Results

Based on the analysis and trends, 5 major regulatory/quality issues and associated risks were identified and involved with overall development. Trends were analyzed by categorizing the warning letters’ severity and its consequences from different geographical locations (such as EU, US, China, India). A thorough due diligence, studying CMO’s quality system and regulatory history provide insights of quality culture within the CMO. A systemic risk assessment tool can mitigate predicted risks.

Conclusion

If the issues raised in Warning Letters are identified, managed, and resolved as a part of the CMO selection process, risks to clinical development and commercial supply can be mitigated (Risks include IND clinical hold, import bans, supply shortages, NDA/BLA Complete Response). Defining expectations from the CMO, roles and responsibilities in the quality agreement, routine and audits, sponsors can make the best out of the outsourced paradigm with minimum risks.