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:
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:
Quantities of materials.
Construction of equipment or instrument
Order of addition of materials
Sequence of unit operations.