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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?
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closed as too broad by OpticalResonator, Sam Farjamirad, Fred, Ethan48, EnergyNumbers Dec 22 '18 at 9:22

Please edit the question to limit it to a specific problem with enough detail to identify an adequate answer. Avoid asking multiple distinct questions at once. See the How to Ask page for help clarifying this question. If this question can be reworded to fit the rules in the help center, please edit the question.

  • $\begingroup$ This looks like a homework question (even if it isn't homework). In order for such questions to be answered in this site, we need you to add details describing the precise problem you're having. What have you tried to solve this yourself? Please edit your question to include this information. $\endgroup$ – Wasabi Dec 22 '18 at 14:32
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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.

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

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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.

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

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