In previous article we understood what is pharmaceutical validation study and scope (phase)of validation. We also saw the history
of validation concept.
In this article we are going to understand the definition
of process validation as per various regulatory agencies, type of process validation and objective
of process validation along with it’s advantages.
Definition
of Process validation:
ICH (International Conference on Harmonization): In
2000, ICH defines definition of process validation in cGMP Guidance document
ICH Q7 that “Process Validation (PV) is the documented evidence that the
process, operated within established parameters, can perform effectively and
reproducible to produce an intermediate or API meeting its predetermined
specifications and quality attributes.”
WHO (Word Health Organization): The
documented act of proving that any procedure, process, equipment, material,
activity or system actually leads to expected result.
USFDA: In 2011,
“The collection and assessment of data, from the process design stage all the
way through production, which establishes logical indication that a process is
capable of consistently delivering quality products.
European Commission: In 2000,
Documented
evidence that the process, operated within established Parameters, can perform
effectively and reproducible to produce a Medicinal product meeting its
predetermined specifications and quality attributes.