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4 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Validation T he words 'method' and 'validation' do not appear together in medical device regulations. Yet, proper validation of methods is expected by regulatory agencies for combina- tion product submissions, even without specific regula- tory guidelines indicating precisely how medical device methods are to be validated. Regulatory authorities commonly investigate methods and validation during the review of marketing applications, and FDA regularly issues 483 observations for improper validation of methods during inspections. Advancements in medical device and ancillary technologies are leading to significant improvements in the new combination thera- pies available to patients. Coating technology advancements allow for devices—such as balloons and stents—that deliver various therapeu- tics enhancing the performance, safety, and efficacy of the treatment. These new developments lead to multifaceted design specifications and manufacturing processes, and they increase the complexity of the device tests and testing requirements. When drugs and biologics are included as device components of a com- bination product, the criticality aspect of testing methods (upon which method validation is based) is heightened and becomes more complex. What defines a combination product? Combination products vary widely in design and application, from a relatively simple pre-filled syringe to a more complex product like a A Method Validation Framework for Combination Products Adam Lambert The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. Adam Lambert, PhD, is a VP, product and process development, for Pharmatech Associates, a USP company. PIXEL-SHOT - STOCK.ADOBE.COM