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
Pharma Quality is a KZbin channel which provides content related to various good practices followed in the pharmaceutical industry based on the practical approach by the industry experts with years of experience.
The channel aims to help organizations, professional and students to know about the regulatory requirements and current Pharma Quality standards.
We help at every step of your growth, career and learning journey.
Join this community to improve the quality and safety of products.
/ @pharmaquality23
Out of specification in pharma
out of specification in pharmaceuticals
oos in industry
Out of specification industrial pharmacy
oos investigation
Out of specification (oos)
laboratory investigation
Out of specification in quality control
out of specifications
out of specification investigation
Quality management system
Qms in pharmaceutical industry
quality management
Oos phase 1 investigation
Oos phase 2 investigation
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.