Process Validation is a practice of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. In Pharma Industry, Process Validation is very important. Apart from final testing and compliance of product, the process adapted to produce itself must assure that process will consistently produce the expected results. Qualification of systems and equipment is therefore a part of process of validation.
Types of Validation:
Design qualification (DQ):
Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS).
Installation qualification (IQ):
Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational qualification (OQ):
Demonstrates that all facets of the process or equipment are operating correctly.
Performance qualification (PQ):
Demonstrates that the process or equipment performs as intended in a consistent manner over time.
Component qualification (CQ):
Refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is GMP compliant.
Equipment qualification involves documenting the entire qualification process in the validation lifecycle, even after the initial qualification each piece of equipment needs to be maintained within the qualified state by ensuring robust periodic review cycles.