Integrating Medical Device & Drug Guidance
My experience was in chemical manufacturing processes that were regulated as a medical devices. As a result, I was using mostly aspects of medical device process validation guidance structure but sometimes using the drug guidance structure. Here's how I integrated the two recommendations:
Process validation begins with the phase called Installation Qualification or IQ under medical device guidance and is included as a consideration under drug guidance. I will call the next phase Operation Qualification or OQ because grammar is important. The medical device guidance and other sources will instead call this Operational Qualification; however, I am on a one-woman crusade to segregate nouns from adjectives. The companion phase to OQ is called Performance Qualification or PQ. The reason I refer to these as companions is that the study design under OQ/PQ for medical devices is somewhat different from what is recommended in the drug guidance. This alternate phase is called Process Performance Qualification or PPQ in the drug guidance.
I'll give an example from my experience just to help you envision how you may decide between the OQ/PQ approach from medical device guidance and the PPQ approach from drug guidance. The example involves mixing powder components into water to create a liquid product. In one instance, I did OQ/PQ while in another, I did PPQ. For OQ/PQ, the tank was used at multiple volumes and had different products with different solubility challenges. So, we included mixing at different volumes and addressing the variety of mixing processes that were necessary based on the formulations. We didn't do every formulation but chose ones that were representative of the worst case to dissolve different components. For the PPQ validation, the tank was used for a single volume and had one product that was a clear worst case versus the other two that were made in the same tank at the same volume. We designed the studies to have mixing speed worst case and used the product worst case but still considered it long term because of having only one batch size applicable.
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About Brayearst Validation Consulting
Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.
