Out of specification (OOS) FAQs
| These FAQs and interactive presentation provide guidance on what to do if an out of specification result is identified during laboratory analysis. 1. Has the MHRA produced any guidance? 2. Why is there a need to conduct an investigation of an OOS test result if the decision has been taken to reject the batch? 3. Who should investigate OOS? 4. How is an out of trend result handled? 5. Is it acceptable for a contract laboratory (contract acceptor) to use the contract givers’ procedure when handling OOS results? 6. How is a meaningful OOS investigation conducted? 7. At what point should a manufacturing investigation be initiated? 8. What should be done if unexpected results are obtained and there is no obvious explanation? 9. Under what circumstances could test results become invalid? 10. What should be done in the case where part way through testing the analyst realises there is an error? 11. When should the analyst inform the supervisor that they have an OOS results? 12. What should be done when the phase 1 investigation does not reveal an assignable cause or evidence of error remains unclear? 13. How many repeat tests should be conducted? 14. What should be done if after retesting there is a combination of OOS results and pass results? 15. What should happen if the OOS investigations are inconclusive? 16. When is it acceptable to average test results? 17. When is it not acceptable to average test results? 18. At what stage should retesting occur? 19. At what stage should re-sampling occur? 20. When is it appropriate to use outlier tests? |
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