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...

Авто/Мото