A Method Validation Framework for Combination Products

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology, Regulatory Sourcebook, March 2022, Volume 2022 eBook, Issue 1
Pages: 4–9

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.

The words ‘method’ and ‘validation’ do not appear together in medical device regulations. Yet, proper validation of methods is expected by regulatory agencies for combination product submissions, even without specific regulatory 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 therapies available to patients. Coating technology advancements allow for devices—such as balloons and stents—that deliver various therapeutics 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 combination product, the criticality aspect of testing methods (upon which method validation is based) is heightened and becomes more complex.

Read this article in Pharmaceutical Technology's March 2022 Quality and Regulatory Sourcebook eBook.


This is part one in a series. Read part two: Common FDA 483 Observations for Combination Products.

About the author

Adam Lambert, PhD, is the VP, product and process development, for Pharmatech Associates, a USP company.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2022
Pages: 4–9


When referring to this article, please cite it as A. Lambert, "A Method Validation Framework for Combination Products," Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook (March 2022).