A firm recently received the following 483-observation relating to the absence of a quality agreement with a laboratory testing facility:
Specifically, your firm contracts third-party laboratories for microbial testing in … API and water, but your firm does not have quality agreements that define GMP responsibilities of each party.
Quality Agreements for microbial testing of APIs and water systems are particularly crucial due to several scientific considerations that demand rigorous attention and standardization. Technical specifications, data integrity frameworks, OOS result management, change controls, and audit mechanisms are essential parts of a quality agreement.
When documented agreements are absent traceability suffers because establishing clear accountability for quality failures becomes problematic during investigations.
When an out-of-specification result occurs or a contamination event is detected, the investigation must determine not only what happened but also who was responsible for each aspect of the testing process. Without written agreements, this determination devolves into conflicting recollections and disputed interpretations rather than clear contractual obligations.
As Annual Product Reviews approach, now is a great time to review your Quality Agreements.
The following are links related to FDA Guidance pertaining to Quality Agreements:
Guidance on Contract Manufacturing Quality Agreements
