Out of Specification Results

Hello everyone,

I have a question with respect to OOS results. I’ll start with an example.
A cGMP company receives a material, performs a test on the material and finds that it is OOS. A retest is done as well, but still yields an OOS result. Manufacturer confirms that the material is fine, by testing on their end. The QC person from the cGMP company then sees that the specification (USP monograph) that the material is being tested against, will be updated in a few months, and if, hypothetically, they re-test it, it’ll make the material in-spec. Until then, the material will be quarantined.

My questions are:

  1. Is it okay to conduct a re-test in this manner?
  2. Will this be considered as a ‘test into compliance’ issue?
  3. If the company agrees for a re-test against the updated spec, and gets audited, what are the required documents or what explanation the company can provide?

Re-testing with the new specifications is not acceptable. This is because, initially, the material was tested as per old specification which was valid at that time (and the material did not comply).
Now after a few months, the same material lot can not be tested as per the new /revised specification to get the results within specification (passing).
In fact, an investigation should be done by GMP company to identify the reason for passing the material by the manufacturer. The material should be analyzed by both parties together (GMP company and Manufacturer) to find out the exact root cause. There has to be a Technical -Quality agreement between both parties BEFORE qualifying the manufacturer (vendor qualification) to supply the material to avoid such conflicts. In the agreement there has to be consensus on the specifications of the materials to be supplied by the manufacturer as a part of ‘Vendor qualification’ process.

This topic was automatically closed 3 days after the last reply. New replies are no longer allowed.