Process Validation in Pharma, FDA Guidance?
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- เผยแพร่เมื่อ 21 ก.ย. 2024
- Process Validation in Pharma, What is FDA Guidance? #usfda #pharma #validation #process @PHARMAVEN
Types and stages of Process Validation and US
FDA Guidance on process validation.
In this tutorial i will correlate the types of
process validation with these three stages of
validation suggested by the US FDA.
There are three are stages of PV:
The stage 1 is Process Design
Stage 2 is Process Qualification
and
Stage 3 is Continues Process Verification.
And there are total 4 types of Validations
1. Prospective validation
2. Concurrent validation
3. Retrospective validation and
4. Re-validation,
Process Validation, Concept, Regulatory Guidance, Challenges and Verification @PHARMAVEN
Your Queries
1. What is Process Validation?
2. What is Continued Process Verification?
3. What is FDA Guidance?
What is FDA Guidance on Process Validation?
5. What is Process Qualification?
6. What is perfomance qualification?
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Good imformation give u Sir👍👍
Excellent explaination
Glad it was helpful!
Very clear explanation sir.. Thank you for sharing value information
Really informative details.... Pls share more vidio related to training...GDP, GMP... Etc
Thanks
I will make
Please also help me in spreading knowledge by sharing these knowledge videos to all your friends and groups and juniors
Thank you sir explained in very lucid way. Please explain types of process validation and which approach company follows nowadays.
Prospective validation is most followed approach. This approach, we do validation first then commercial production
Concurrent validation which is not preferred by FDA is ongoing validation during commercial production
Earlier third approach called retrospective validation where data of old batches were being used to prove that process is Valid. This approach is no more valid now and no one uses it, not allowed by FDA.
Very nicely explained 👍
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Pls Explain compounding vessels validation process and its criteria sir
Very nice sir
great
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
Sir any videos on Change control system?
I have uploaded
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Spread the knowledge 🎉🙏
Good explanation Sir
can i take deviation in validation batches if my pre defined parameter deviates in process validation batch
What parameters are deviated?