Process Validation FAQs

How many types of validation are there in pharmaceuticals?
There are four types of validation in pharmaceutical industry: Prospective validation, Concurrent validation, Retrospective validation & Revalidation

What are the stages of process validation?
As per FDA, there are three stages of process validation: Stage 1 – Process Design, Stage 2 – Process Qualification & Stage 3 – Continued Process Verification.

Why is process validation important in pharmaceutical?
process validation is important to ensure that the process is capable of reproducible commercial manufacturing.

Why are there (3) batches for process validation?
Consideration of validation batches fewer than three will require more statistical and scientific data to prove the consistency of process to meet quality standards. Therefore, minimum three consecutive batches are evaluated for validation of manufacturing process and cleaning procedures.

Only reference to magic number 3 you can find in EMA guidance on process validation of finished products. The guidance does not mandate minimum of 3 batches but seen many interpret this as requiring 3 batches and to meet both FDA and EMA requirements they default to 3 batches.

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