Mastering Out of Specification (OOS) in the Pharmaceutical Industry: A Step-by-Step Guide

This video will explain about:
1. What is Out of Specification?
2. Important definition used in OOS investigation.
3. Guidance for Industry.
4. Handline of OOS (Details workflow).
5. Phase I - Laboratory Investigation.
6. Phase II - Full-Scale OOS Investigation.
7. Practical Approach to make an investigation report for OOS.
#oos
#outofspecification
#outofspecificationinpharma
#qualitymanagementsystem
#qms
#production
#pharma
#pharmaceutical
#quality
#qualitycontrol
#qualityassurance
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What is out of specification
Define oos

[@preetampradhan2328]

Sir please prepair one video on effectveness monitoring.

[@PharmaQuality23]

Sure

[@Rakesh-wj9vn]

What is the difference between oos and OOL

[@PharmaQuality23]

OOS indicates quality issues with the product itself, when analytical results observe out of specification against an established specification limit., while OOL highlights a process control or monitoring concern, when any limits are observed out of limit against established limits.