Confidence in Quality - Ongoing Risk Management

A Contract Manufacturing Organisation (CMO) conducting a complex process over several weeks notified a Sponsor about 76 unplanned events that occurred during manufacture of their Drug Substance. This was good practice and allowed the Sponsor to have oversight of the process, but was rather overwhelming. 

The large number of notifications meant that it was difficult to identify the events potentially impacting product quality. The Sponsor needed to understand and assess any potential risk to product quality, as well as the suitability/performance of the vendor.  

With the support of JWQC, the team were able to:  

• liaise with the CMO to understand the details of all unplanned events, and triage, in line with the Principles of Quality Risk Management  

• work with Subject Matter Experts to assess any impact on product quality 

• collaborate with the CMO to conduct risk assessments, and identify actions to reduce process and system risks moving forward to the next manufacturing campaign 

• highlight where additional Sponsor oversight of the CMO was needed moving forwards 

The result of this collaborate approach was confidence in the quality of the end product, increased understanding and control of risks associated with the manufacturing process, and an improved Vendor/Sponsor relationship for future manufacturing campaigns.