Packaging Performance Qualification—A Risk-Based Approach | IVT

This paper focuses on packaging performance qualification as an example, but in practice the concept can be introduced for all mechanical processes because the process characteristics are all similar.  In the longer term, this methodology will be proposed as “Annex C” to the Global Harmonization Task Force’s (GHTF) Quality Management Systems–Process Validation Guidance (1).  Download "Packaging Performance Qualification—A Risk-Based Approach"