Typical OOS examples with investigation and recommendations

Two examples of routine OOS investigations are discussed. It is necessary to investigate thoroughly to get the real root cause of failure. FTA tool of ICH Q9 is very useful. MHRA guide titled Out Of Specification Investigations and the CDER guide titled - Guidance for Industry, Investigating Out-Of-Specifications (OOS) Test Results for Pharmaceutical Production will give adequate details, investigations in various phases. - Ramalinga Prasad Kuppa.

[@KP-vd5ws]

Thank you sir

[@dedeepyagamingchanel2444]

I have ever seen explanation with this much clarity

[@pharmaworldk1473]

I am happy to note your comments. I believe that the analyst should have such a focus on the technical requirements. It is necessary to understand the intent of requirements fully...if so, OOS investigation will be very fruitful.