Question from a validation beginner in the pharmaceutical industry.
- What are the common approaches to start writing validation protocols (esp. IQ, OQ, PQ)?
- 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.
Operational Qualification (OQ): Procedure to validate the equipment or product parameters
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.
Sometime some of these steps are combined, such as OQ and PQ.