What is preliminary investigation in OOS

Question

Accepted Answer

Preliminary investigation in OOS refers to the initial inquiry conducted to identify the potential causes of an Out-of-Specification result.

Preliminary investigation is a crucial step in determining the root cause of an OOS result.
It involves gathering relevant information, reviewing documentation, and conducting initial tests or analyses.
The purpose is to identify potential factors that may have contributed to the OOS result.
Examples of preliminary investigation activities include checking equipment calibration, reviewing sample handling procedures, and examining environmental conditions.
The findings from the preliminary investigation guide further in-depth investigations to determine the actual cause of the OOS result.

Accepted Answer

Out of specifications as per bmr &bpr

Accepted Answer

Inspect the product for any signs of tampering or abuse. ...

Check the ingredients and purity of the product. ...

Analyze the performance of the product using appropriate testing methods. ...

Determine w...read more

Accepted Answer

Inspect the product for any signs of tampering or abuse. ...

Check the ingredients and purity of the product. ...

Analyze the performance of the product using appropriate testing methods. ...

Determine why the product is out of specification.

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