Is risk analysis prerequisite for a process validation. Can’t critical points be selected on the basis of past experience?

I Think past experience means you are talking about retrospective validation. A process validation can be done in prospective way only & retrospective validation does not generally applies to process validation.


Dear Sunita,

risk assessment is not necessarily a prerequisite but can greatly reduce the workload of a validation. Past experience is invaluable to select the critical points. Both together make up a good critical point selection, but risk assessment alone is a non confirmed probability estimation, and past experience alone, if not statistically confirmed, does not say anything about the likeability of reocurrence of the event, deviation, or whatsoever. For products new to the market, the risk assessment has more weight, for older products the past experience is more important.

Best regards