The most recent GMP Trends Report highlights a striking observation relating to a firm’s failure to adequately qualify a contract testing laboratory. In the 483, the FDA investigator explained:
“Your Quality Unit failed to perform a thorough vendor qualification of a contract laboratory that as part of a Quality Agreement performs both raw material and final product testing for …. The last vendor qualification performed by the Quality Unit was documented by a survey checklist conducted four years ago, and no site audit was documented to be completed to verify the contract laboratory capabilities to perform raw material and final product testing for an application product. The … has been commercially released for the last 3 years and there are currently lots available in the market within expiry.”
This 483 is a startling omission of quality compliance. It is paramount to recall that the product manufactured and tested at a contract organization is a direct reflection of your own quality standards. While outsourcing can improve efficiency, FDA makes clear that sponsors retain full responsibility for ensuring testing is reliable and compliant.
Vendor qualification requires ongoing oversight, which includes site audits, documented reviews, and risk-based requalification. GMP Trends Clients utilize our GMP Trends Annual Report as a resource for designing organizational audits.
The following are great FDA references relating to Quality Agreements and Audits.
CFR Citation relating to evaluation of partner organizations: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-E/section-820.50
FDA Guidance on Contract Manufacturing Quality Agreements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry
