ViP Definition
"Process Validation is the provision of documented evidence to demonstrate that a registered process consistently produces a product, which meets its predetermined specification and quality characteristics."
Process Validation has traditionally been considered to be the manufacture of three consecutive replicate batches of product and requires qualified systems, validated cleaning and analytical methods, approved working instructions, trained personnel, and controlled documentation.
At ViP we recommend the expansion of this definition
to encompass the trending of key/critical process parameters
over time. This provides support for annual reviews
and the associated rationales with respect to minimising
the requirement for revalidation, while perfectly integrating
with the FDA's Risk-Based Approach and Process Analytical
Technology (PAT) initiative.
Although execution of Process Validation is the responsibility
of trained company personnel, ViP can assist in the
development of process validation protocols/programmes
and supervision of initial activity.
Contact us to find out how we can be of assistance: > CLICK HERE <
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