Medical device packaging validation can be confusing, so here are a few helpful resources to guide your efforts.
In the medical device packaging community, validation, qualification, compliance, and documentation are sometimes used interchangeably. If the terminology can be misinterpreted, imagine the challenges in dealing with the actual complex validation processes.
Pharmaceuticalvalidation.blogspot offers a series of informative articles, including Medical Packaging Validation: Complying with the Quality System Regulation and ISO 11607, Meeting FDA Process Validation Requirements, a 25-year retrospective on sterilization validation, and common pitfalls that can occur during package development and validation.
Just announced by CRC Press is a new book, “Validating Medical Packaging,” by Ronald Pilchik, a healthcare manufacturing veteran with more than 30 years of experience.
