Question from a validation beginner in the pharmaceutical industry.

  1. What are the common approaches to start writing validation protocols (esp. IQ, OQ, PQ)?
  2. What are the common approaches to start executing validation protocols?

Commonly validation protocols are derived from Requirements documents. Therefore review the requirements document to create the validation protocol.

Installation Qualification (IQ): Procedure to evaluate the means of the equipment and the testing of it material. Below is an example of IQ document.

enter image description here

Operational Qualification (OQ): Procedure to validate the equipment or product parameters

enter image description here

Performance Qualification (PQ): This processes mostly like a stress test, that will validate the boundary conditions. For example if the Motor is specified to run at a minimum speed of 25 RPM and a maximum speed of 150 RPM, this process will test and document the results.

enter image description here

Sometime some of these steps are combined, such as OQ and PQ.

Your Answer

By clicking "Post Your Answer", you acknowledge that you have read our updated terms of service, privacy policy and cookie policy, and that your continued use of the website is subject to these policies.

Not the answer you're looking for? Browse other questions tagged or ask your own question.