ARTICLES BY JOY MCELROY
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An Introduction To Quality Agreements For Pharmaceutical Outsourcing4/17/2020
Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
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Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations7/16/2018
Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use.