A process is the controlled interaction of components,
equipment, environment, software and personnel to produce a product
or achieve an acceptable outcome.
GRC Mott MacDonald provides the consulting expertise to
demonstrate through appropriate testing that the finished product
produced by a specified process meets all release requirements for
quality.
The process validation protocol describes a plan that demonstrates
consistency and reliability in processing and confirms that all
component, processing and product specifications are appropriate
and attainable under ideal and challenged conditions.
The Process Validation effort typically occurs after
the Installation Qualification (IQ), Operational Qualification
(OQ), and (when required) a Performance Qualification (PQ) have
been satisfactorily completed.
Successful process validation requires thorough process
development, identification of controlled and critical parameters
and in-process and final product specifications. Typically at a
minimum three consecutive lots of product meeting the established
quality specifications are necessary for process validation. These
three consecutive lots are completed at the boundaries of critical
parameters.
