Implementing best practices for managing Contract Manufacturing Organizations (CMOs) is essential to address potential challenges that can impact product quality. A recent FDA warning letter to AACE Pharmaceuticals serves as a reminder of the critical importance of rigorous CMO oversight.  Without proper supervision, CMOs can encounter serious issues, such as aseptic processing failures and falsified laboratory records, ultimately compromising product quality. These challenges affect not only manufacturers but also extend to distributors and, crucially, to patients.

While these challenges are common in the industry, a commitment to robust compliance and quality assurance can help mitigate risks. Effective supplier management goes beyond contractual agreements and reputation; it requires thorough risk assessments and ongoing evaluations to ensure compliance with Good Manufacturing Practices (GMP). By implementing proactive measures, companies can safeguard against regulatory risks and potential reputational damage.

A key takeaway from the FDA’s findings is the necessity for strong traceability and documentation. The inspection revealed that Brassica Pharma, the CMO in question, had issues with falsified records and poor hygiene practices, indicating weak management controls. Companies must prioritize close monitoring of suppliers and maintain transparent, reliable documentation to identify potential issues early.

Additionally, managing CMOs requires collaboration across departments, including Quality, user departments, and Procurement. Regular on-site audits and performance evaluations are vital practices that enable teams to identify and address problems before they escalate. Companies must also maintain a comprehensive emergency response plan, ensuring that quality teams can act swiftly to protect patient safety and adhere to regulatory requirements.

In summary, to improve CMO management, companies should focus on:

• Strengthening qualification processes
• Requiring complete and transparent documentation
• Maintaining ongoing monitoring and evaluation of suppliers
• Training internal teams on supplier-related risks
• Fostering improved communication within the supply chain

By employing these strategies, companies not only mitigate potential regulatory issues but also ensure the highest standards of product quality. Bora Biologics remains dedicated to advancing our practices and leading by example in the biopharma industry.

About the Author

Apple Cheng has over 11 years of experience in the biopharmaceutical industry, having joined Bora Biologics in 2014. In her role as Sr. Manager of Quality Assurance, she is responsible for ensuring the highest standards of quality and compliance throughout the organization. Apple holds a Bachelor’s degree in Nutrition, which has provided her with a strong foundation in health sciences and quality management. Her dedication to excellence and commitment to quality continue to drive Bora Biologics’ mission in advancing biopharmaceutical innovations.