Mastering Out of Specification (OOS) in the Pharmaceutical Industry: A Step-by-Step Guide
Вставка
- Опубліковано 6 вер 2024
- 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
Sir please prepair one video on effectveness monitoring.
Sure
What is the difference between oos and OOL
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.