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

Описание к видео 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

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