Validation (drug Manufacture)

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