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  • Fady Khalla started the topic Process Revalidation in the forum Process Validation and Process Risk 8 years, 7 months ago

    Dr. Simon introduced process validation and IQ/OQ/PQ concepts this week. Based on 21 CFR 820.75, if any changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented. In one of my previous experiences, The operations team wanted to install equipment to be used in multiple location. The quality team argued that each time the equipment gets moved from one location to another, all processes have to be revalidated.

    What is your input on this? have you ran into similar situations?