validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Monday, January 1, 2018
Present and Future Changes to Packaging Industry Standards
Packaging standards continue to develop and evolve a decade after the most recent version of ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices. This presentation will provide an overview of the changes that are currently being discussed as well as working items that are under consideration that could affect the standards tomorrow. It will touch on the changes to the pharmaceutical packaging industry with regards to USP Guidance chapter 1207 PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS and Medical Device ASTM method work item developments and updates.
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