Mastering Deviations Handling in the Pharmaceutical Industry: A Step-by-Step Guide
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- เผยแพร่เมื่อ 12 มิ.ย. 2024
- 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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Important knowledge shred with us,please make investigation tools sir
Will make it soon..
Thank you 😊
Sir change of supplier for excipients..means change control na ? Who should rise change control
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.
I want to learn line clearance
Can you provide that
Will try to make a video on it.
Is planned deviation now considered as temporary change control ? Or is it still a different terminology
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.
Which guideline mentions about PLANNED DEVIATION...?Only WHO proposed for planned deviation...Please give the exact guideline reference..
Please check below
www.thefdagroup.com/blog/deviation-management
www.gmp-compliance.org/gmp-news/gmp-are-there-planned-deviations