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Process Validation


Process validation: It can be defined as the documented evidence which provides a high degree of assurance that the process which is going to be performed will consistently produce a product , meeting its pre determined specifications and all the quality attributes.

Process Validation is classified into four types which are as follows:

Prospective Validation

Retrospective Validation

Concurrent Validation

Revalidation

Process Validation is divided into three stages which are  as follows:

Process Design - Stage I

Process Qualification - Stage II

Continued Process Verification - Stage III

The Process Validation which is going to be performed only starts after the qualification of equipment or instruments and the qualification of facilities.

Examples of some of the process parameters are:

Temperature

Pressure

Flow rate

Vacuum

Cooling rate

Agitation speed

Time (Duration)

Quantities of materials.

Construction of equipment or instrument

Order of addition of materials

Sequence of unit operations.


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