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Process Validation in Pharma, FDA Guidance?

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PHARMAVEN

PHARMAVEN

Күн бұрын

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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Пікірлер: 19
@AmitSolankii451
@AmitSolankii451 5 ай бұрын
Good explanation Sir
@MuhammadHaroon-lz6xf
@MuhammadHaroon-lz6xf 3 ай бұрын
Excellent explaination
@PHARMAVEN
@PHARMAVEN 3 ай бұрын
Glad it was helpful!
@jigneshpatel1894
@jigneshpatel1894 3 ай бұрын
Good imformation give u Sir👍👍
@msd6178
@msd6178 Жыл бұрын
Very clear explanation sir.. Thank you for sharing value information
@avinashkadam6745
@avinashkadam6745 Жыл бұрын
Thank you sir explained in very lucid way. Please explain types of process validation and which approach company follows nowadays.
@PHARMAVEN
@PHARMAVEN Жыл бұрын
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.
@rgcoll9588
@rgcoll9588 Жыл бұрын
Really informative details.... Pls share more vidio related to training...GDP, GMP... Etc
@PHARMAVEN
@PHARMAVEN Жыл бұрын
Thanks I will make Please also help me in spreading knowledge by sharing these knowledge videos to all your friends and groups and juniors
@nirmalsartana4061
@nirmalsartana4061 Жыл бұрын
Very nice sir
@PharmGrow
@PharmGrow Жыл бұрын
Very nicely explained 👍
@PHARMAVEN
@PHARMAVEN Жыл бұрын
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
@Pharmainform
@Pharmainform Жыл бұрын
great
@PHARMAVEN
@PHARMAVEN Жыл бұрын
Thanks a Lot, kindly also share to your friends and groups and juniors 🎉
@sivakella8581
@sivakella8581 Жыл бұрын
Pls Explain compounding vessels validation process and its criteria sir
@Robby2vlogs
@Robby2vlogs Жыл бұрын
hattsoff
@PHARMAVEN
@PHARMAVEN Жыл бұрын
Spread the knowledge 🎉🙏
@adityabhatia1862
@adityabhatia1862 7 ай бұрын
Sir any videos on Change control system?
@PHARMAVEN
@PHARMAVEN 7 ай бұрын
I have uploaded kzfaq.info/get/bejne/fZ11pMaQra_HZWQ.htmlsi=EyLcOKK2Hea8mx3X
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