To Book your copy today click the link on Amazon.in (India) & Amazon.com(For global)There are repeated observations of US Regulatory Inspectors about OOS investigations.
One recent case study-
FDA Warning Letter due to GMP Violations when handling OOS Results
During their visit to a US contract laboratory, FDA inspectors found basic GMP violations in the following areas:
Handling of OOS results (21 CFR 211.192).
Lack of verification of test methods (21 CFR 211.165(e))
Lack of integrity of electronic data (21 CFR 211.68(b))
1. OOS was observed but without investigating the OOS results, new test preparation was done
2. The root cause investigation was not taken place, the Reason for OOS Result was not clarified.
3. The SOP for handling OOS results did not contain any corresponding regulations.
4. Laboratory staff was given permission/freedom to proceed with such cases, which is not compatible with the GMP rules.
5. The requirements for handling OOS results are described in the Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. Which is not followed.
6. Response was given but it was also inadequate. Because it was still not complying with the guidance.
7. Still it was missing regulations on the invalidation of OOS results. In addition, no retrospective review was conducted that could have served as evidence to fully identify and investigate all OOS results.
Lack of Verification of Test Methods
8. The same analytical method was used for the determination of the content of the active substance in finished products with different formulations - without providing evidence in each case that the method was also suitable for this purpose.
9. In the same way, i.e. without proof of suitability, the same pharmacopoeial methods were also used to test for microorganisms in different products.
10. The FDA considered the data obtained with the test methods to be not error-free (accurate) and rated the time frame given in the response for the subsequent performance of method verification studies as inadequate.
There are more observations... Shall discuss this later.
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