Pharmaceutical Manufacturing Dashboard 2017 Review

1. Case Study
Initial OOS Invalidation without adequate investigation
and addressing potential manufacturing causes
November 2017
US-FDA
Obaid Ali, RPh. M.Phil, Ph.D.
Civil Service Officer, Government of Pakistan

3. Assay goes out

4. Assay goes out Investigation found comparable results of multiple tests

5. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results

6. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest

7. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest
Last sample have different result

8. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest
Last sample have different result It is compliant

9. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest
Last sample have different result It is compliant
Firm rejected multiple values close to the original OOS
result …. Declared initial result as an outlier and released
batch on the basis of last sample …. Investigation failed to
identify laboratory root cause

10. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest
Last sample have different result It is compliant
Firm rejected multiple values close to the original OOS
result …. Declared initial result as an outlier and released
batch on the basis of last sample …. Investigation failed to
identify laboratory root cause

11. Assay goes out Investigation found comparable results of multiple tests
2nd Analyst found 3 same results But, tested again, not the retest
Last sample have different result It is compliant
Firm rejected multiple values close to the original OOS
result …. Declared initial result as an outlier and released
batch on the basis of last sample …. Investigation failed to
identify laboratory root cause

12. Don’t declare the original OOS as an “outlier” and use
the retest without establishing the root cause
Such statistical treatments can’t always identify the
cause of an extreme observation
Take Home Message
Set the Tone on Full Compliance Mode

13. Retesting into compliance was never
encouraged, now it is intolerable and have
regulatory consequences
Take Home Message
Set the Tone on Full Compliance Mode

14. Review critically every decision & actual
practice to record every data value …..
Save yourself from being a victim of testing
into compliance with sincere intentions
Take Home Message
Set the Tone on Full Compliance Mode