Type of Validation
Prospective
Validation
Validation conducted before the distribution of either a replacement product or product created beneath a revised manufacturing methodology, where the revisions may affect the Product’s characteristics.
Validation conducted before the distribution of either a replacement product or product created beneath a revised manufacturing methodology, where the revisions may affect the Product’s characteristics.
Concurrent
Validation
Validation process is carried out during normal
production.
This method is effective only if the development stage
has resulted in a proper understanding of the fundamentals of the process. The
first three production –scale batches must be monitored as comprehensively as
possible.
Concurrent validation beside a Associate in Nursingalysis|analysis|analytic thinking} together with stability ought to be applied to an acceptable extent throughout the lifetime of the product.
Concurrent validation beside a Associate in Nursingalysis|analysis|analytic thinking} together with stability ought to be applied to an acceptable extent throughout the lifetime of the product.
Retrospective
Validation
Validation of a method for a product already in distribution primarily based upon accumulated production, testing and control data.
Validation of a method for a product already in distribution primarily based upon accumulated production, testing and control data.
Yes, you can! But regulators do not like!
–
Must
be robust process
–
No
unexplained failures
–
More
than 30 consecutive acceptable batches
–
Must
use statistical analysis
–
Use
Cp and Cpk (Process capability)
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