3 stages and 4 types of Process Validation | FDA Guidance on process validation

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,
Here is the link for How to perform FMEA| Process steps and Risk Calculation| Failure Mode and Effect Analysis|ICH Q-9
• How to perform FMEA| P...

[@rutujapatankar19]

Nicely explained. Thankyou

[@pharma8975]

Nice explanation and superb

[@PrasannaKumar-vm9rt]

Can you describe simply by denoting giidline name and number along with 21 cfr, anvisa , ich, other guidelines. Means
Which guidelines refer to validation, qualification, investigation, risk assessment, change control, deviation, incidents, capa, root cause analysis, sampling techniques, manufacturing and packing, gdp, gmp. Etc
Plz awaited for response.

[@vijayaramakrishnapilli8583]

very nice explanation

[@amitkumarshukla3234]

Very good explanation

[@kiranubbu3186]

Tq excellent information

[@ramuboppani9254]

Thanks for sharing

[@PharmaPill]

👍🏻

[@syedmuzamilshah8316]

superb

[@Smittaji]

Audio is having too much base & subtitle is typing something which cannot be related to the conversation. good video, very hard to understand with the audio issues

[@sailalith1989]

Excellent it's helpful for me am IPQA Chemist.

[@arvindrajput986]

Bro....Where? City

[@IK-qu9hw]

Very nice.
I am instrumentation engineer 2017 batch. After completion of degree I started working in automation field ( I have done oq ,pq of blender, RMG ,FBD machine also 21 cfr part 11 with end client. ) now I have 1 yr experience in automation field.since salary package is very less so now I am thinking to switch to pharma sector, I have one question what should I do now shall I switch to pharma or not?
Plz reply..

[@vanjinathan6561]

Chicken TBH 4th CCTVbut v chubby

[@boinikrishna3364]

Sir in pharma IPQA vs AR&D which is best sir for better growth.. Please give me reply sir..

[@jigishapatel4487]

Sir, can you please explain Process validation for EMA also ?? How does it differ there ??

[@badithalakishorekumar112]

Good information

[@vinayak8055]

If long time years validation not done then there is need of revalidation ? Even there is no any change in process.OR It's available of any period of revalidation?

[@vaidikchetanmanch4858]

Super se bhi upar

[@pratikshawavale]

Thanks for the guidance .keep making more videos for pharma learner like me.

[@krishnanvisva4137]

Super sir

[@ParthPatel-wn6sp]

Please explain latest Process Validation theory.

[@girijarithi6806]

Super

[@govardhanreddy1891]

How many batches to take for re- validation

[@anilreddy1650]

Sir which guide line is supporting.

[@ajayspecial3936]

Superb

[@pharmalearners3120]

Thank you Ajay

[@munduruganesh3651]

👌

[@pharmalearners3120]

Thank you

[@ravinpawar8638]

Good ppt

[@khushbookanojiya749]

Gud video but Plz Hindi m bhi discribe kare

[@niharranjanmeher4989]

Sir..Plz remove the background music...

[@kartheekgoud5385]

Sir, why 3 batches are required for process validation??

[@himanthmanne8447]

look at the FDA regulations

[@vishal11ism]

Two batches are not enough to provide statistic data, and 4 batches can be done but will be time consuming and pricey.

[@abhishekdhiman8222]

Sir... Background music ko band kare

[@Rakeshkumar-xo2xv]

Plz speak in Hindi......

[@pharmalearners3120]

Thank you Rakesh for your suggestion, I will definitely implement it in future