OOS investigation guidelines

Question

Accepted Answer

OOS investigation guidelines are a set of procedures followed to investigate out-of-specification results.

OOS investigation guidelines are used to identify the root cause of the out-of-specification result.
The investigation should be conducted by a trained investigator.
The investigation should be documented and include all relevant information.
The investigation should include a review of the manufacturing process, equipment, and materials used.
The investigation should also include a review of the testing procedures and methods used.
The investigation should be completed in a timely manner.
Corrective actions should be taken to prevent recurrence of the out-of-specification result.
The investigation report should be reviewed and approved by management.

Accepted Answer

Out of Specification (OOS) specifically delivered in the process step and Quality analysis check during the product along with efficiency.

Accepted Answer

As such there is no guidelines for oos investigation it depends on how you can do dig and dipper investigation. There only FDA's Guidance for Industry

"Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production".

The guidance document for investigation that explains how to do investigation. If want can check the detail parameters check here.

OOS investigation guidelines

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