Process validation is a documented program, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
We follow the following system with regard to process Validation:
i) Establish specifications and performance criteria.
ii) Select methodology, process & equipment to ensure the product meets the specification.
iii) Test the final product using validated analytical methods in order to meet specification.
Following steps supports the above steps:
i) Calibration, verification and maintenance of process equipments.
ii) Qualification of both process & equipment.
iii) Challenge, audit, monitor or sample the recognized critical or key steps in the process.
iv) And finally when there is a significant change in the product or Process. Re-qualify or revalidate the process