If you are evaluating a new contract manufacturing organization (CMO), do you know what to look for in a new CMO?

Keep in mind that companies that outsource manufacturing operations are still responsible for ensuring quality.

This means that it is critical to partner with the appropriate CMO.

At the 2021 PDA/FDA Joint Regulatory Conference, Genentech/Roche Executive Director and Global Head of External Development Collaborations Emma Ramnarine explained that the relationship between a company and a CMO or supplier should begin by discussing risk management approaches with both entities by identifying and classifying risks.

In a separate PDA/FDA presentation, Amgen Vice President of Corporate Quality Lisa Dierl stated that it is important to be aware of a CMO’s investigations processes, including CAPAs. This includes ensuring that a CMO has a strong, top-down quality culture across the organization.

Of course, a quality agreement between both parties will be necessary. A quality agreement includes information on the roles, responsibilities, and procedures for manufacturing product. The goal of this document is to ensure that no matter who manufactures a product, manufacturing addresses quality concerns and that both parties are on the same page. 

Outsourcing of manufacturing is often a necessity for small pharma and biotech firms. But it is also extremely important to ensure that a CMO has a robust quality culture. Some recent issues involving CMOs include an inadequate CAPA following microbiological contamination in a water system and incorrect assay specifications for a tablet

As manufacturing operations become more complex and reliance on CMOs expands, selecting the appropriate CMO is more critical than ever.

Additional Resources

Ensure Adequate Investigations at Your CMO With a QRM Mindset     

How One Pharma Firm Ensures Robust GMP CAPA Effectiveness at CMOs

Quality Agreements: Part I, Why They are Critical

Case Study of Contaminated WFI in China

Incorrect Specifications, Process Validation Issues at CMO Lead to Adverse Events, Recall

Using Redica Systems’ Benchmark Report, you can compare the regulatory enforcement histories for a group of sites. This can come in handy when you are in the market for a new CMO or vendor. Contact us today to see how we can help you monitor enforcement actions involving your vendors and CMO.

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