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Process Validation

Process Validation new definition from the FDA is “the collection and evaluation of data, from the process design phase through production, which establishes evidence that a process is capable of consistently delivering quality products.”   This needs to be performed when the process is not fully verified by inspection or testing.   For injection molding of critical components, this detailed and successful process validation must be defined and approved after producing parts that consistently perform according to customer specifications before production can be begin.

Before beginning process validation for injection molding, it is important to understand the manufacturing process and the product specifications.   Experimentation by changing process parameters to determine which process variables having more impact on the product as well as how far those process variables can be varied while still manufacturing product that is acceptable and meets customer specifications.    Also, a clear definition of product specifications must be determined using scientific units of measure and defined limits and include industry standards whenever possible.

There are three elements in the process validation process that play critical role in the injection molding process which are IQ, OQ and PQ.  Each of these elements need to be approved before proceeding to the next element.

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