Validation (drug Manufacture)
In the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries, validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
- Cleaning validation
- Process validation
- Analytical method validation
- Computer system validation
Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:
- Design qualification (DQ)
- Component qualification (CQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
Read more about Validation (drug Manufacture): History, Reasons For Validation, Validation Master Plan, The Validation Process, Computer System Validation, Scope of Computer Validation, Risk Based Approach To Computer Validation