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Section 21 CFR 211 of Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals includes detailed requirements for OOS investigations:

  • 211.84 Components, product containers, and closures need to be tested and approved or rejected based on results
  • 211.113 Microbiological contamination needs to be controlled
  • 211.160 Lists general requirements
  • 211.165 Covers the testing and release for distribution
  • 211.194 Lays requirements for laboratory records of testing and validation, ensuring the conforming of components, containers and closures, in-process materials, and finished products to specifications.

CGMPs also include OOS investigation requirements for active pharmaceutical ingredients (APIs), to be conducted by manufacturers and contract testing laboratories. It should include testing of raw materials, monitoring of processes, release and stability testing, validating process, and investigations of OOS results.

As per FDA regulations 211.192, an OOS test result needs to be investigated further to identify the root cause and establish whether it is an aberration of the measurement process or the manufacturing process.

In case a batch has to be rejected because of an OOS result, further investigation to ascertain whether the result is true for other batches of the same drug product or other products is essential. Batch rejection does not eliminate the need for further investigation. Also, documentation of the study, the conclusions, and the follow-up process are critical regulatory requirements.

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