Types of Process validation:Out of four types prospective validation is one of them. Some points regarding prospective validation are as follows , so let us check it out one by one:
In prospective validation process the validation is carried out based on the pre planned protocols.
Prospective validation is carried out at new process at new manufacturing facility.
Before pharmaceutical production at commercial level, prospective validation is carried out.
During prospective validation the input resources are clearly defined and specified.
Material specification, operating parameters, equipment and process parameters and the people are trained or not must be clearly defined.
Output is studied and the various specifications are defined.
After repeated experiments the standard specifications are defined.
Studies are carried out at laboratory scale and then they are scaled up to pilot plant.
After all studies finally the variables, process parameters and the specifications are decided.
Documentation of all the batches which are studied are prepared.