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View Full Version : Equipment Qualification - IQ, OQ and PQ evilchilli_420 1st October 2009, 02:52 AM Hi, I am a grad student and I have a question: How can we design, analyze and execute IQ/PQ/ OQ for equipment, processes used for testing of biomedical products and are there any guidance documents? Thank U. SteveK 1st October 2009, 04:23 AM Hi, I am a grad student and I have a question: How can we design, analyze and execute IQ/PQ/ OQ for equipment, processes used for testing of biomedical products and are there any guidance documents? Thank U. Hi Evilchilli, As a starting point try GHTF (validation guidance for medical device processes) at http://www.ghtf.org/sg3/sg3-final.html. Steve Ajit Basrur 1st October 2009, 06:11 AM Hi, I am a grad student and I have a question: How can we design, analyze and execute IQ/PQ/ OQ for equipment, processes used for testing of biomedical products and are there any guidance documents? Thank U. Welcome to the Cove :bigwave: Pl note that I have moved your question to the Qualification and Validation to get more specific responses. Steve has provided a very apt link - pl come back if you have further questions. :) |
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