Mastering Deviations Handling in the Pharmaceutical Industry: A Step-by-Step Guide

  Рет қаралды 3,739

Pharma Quality

Pharma Quality

Күн бұрын

This video will describe about:
1. What is deviation?
2. What are the regulatory guidelines for deviation?
3. Types of deviations?
4. Categorization of deviations?
5. Categorization of deviations?
6. Handling of deviation (details workflow).
7. Practical approach to make an investigation report for deviation.
#deviation
#deviations
#changecontrolinpharma
#qualitymanagementsystem
#qms
#production
#pharma
#pharmaceutical
#quality
#qualitycontrol
#qualityassurance
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Пікірлер: 10
@rkchannel4797
@rkchannel4797 3 ай бұрын
Important knowledge shred with us,please make investigation tools sir
@PharmaQuality23
@PharmaQuality23 3 ай бұрын
Will make it soon.. Thank you 😊
@foodbloggers5836
@foodbloggers5836 Ай бұрын
Sir change of supplier for excipients..means change control na ? Who should rise change control
@PharmaQuality23
@PharmaQuality23 Ай бұрын
When changing the supplier for an excipient, it should be managed through a change control process. Generally, it should be initiated by the QA and evaluate for potential risks and impacts on product quality and compliance.
@shwetakarkhile
@shwetakarkhile 2 ай бұрын
Is planned deviation now considered as temporary change control ? Or is it still a different terminology
@PharmaQuality23
@PharmaQuality23 2 ай бұрын
Planned deviations and temporary change controls involve managing deviations from standard procedures. I think most industries use temp Change to handle this, however it depends on time duration, purpose and scope.
@tammisettikishore9233
@tammisettikishore9233 Ай бұрын
I want to learn line clearance Can you provide that
@PharmaQuality23
@PharmaQuality23 Ай бұрын
Will try to make a video on it.
@vsrpinternational3863
@vsrpinternational3863 3 ай бұрын
Which guideline mentions about PLANNED DEVIATION...?Only WHO proposed for planned deviation...Please give the exact guideline reference..
@PharmaQuality23
@PharmaQuality23 3 ай бұрын
Please check below www.thefdagroup.com/blog/deviation-management www.gmp-compliance.org/gmp-news/gmp-are-there-planned-deviations
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