What is Process Validation?

Validation for ExcipientsThe concept of validating pharmaceutical processes or, in FDA’s definition, “the establishment of scientific evidence that a process is capable of consistently delivering quality product across its lifecycle”, was first introduced to the FDA in the 1970s.  The idea behind pharmaceutical validation was to build quality into pharmaceutical products by ensuring that processes are robust and will routinely meet specification and customer expectation.  When processes are considered validated they are designed to perform reliably and routinely to produce conforming product.  When quality processes are built into the manufacturing process and the final testing performed on the drug product is done only as confirmation, the final product is not “tested into compliance”.    When patients take medicines, they expect that there is little to no variability with how their medicine was made and they rely on the manufacturers to validate critical processes to ensure process reliability and reproducibility.  From batch to batch, or, from the patient’s perspective, from prescription refill to refill, the product should always be produced the same way and have the same efficacy.

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