According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
INTRODUCTION. What is Validation? PACKAGE DESIGN VALIDATION. Elements of Package Design. Package Design Issues. Validation Flow Chart. Simulation Criteria. Qualified Suppliers. PACKAGE PROCESS VALIDATION. Introduction. Process Validation. IQ, OQ, PQ. Process Capability Studies. Example. PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL. The Validation File. File Maintenance. Employing the Process. Example. REGULATORY ACTIVITIES. Selected Case Studies. Packaging Non-Compliances. Industry Generated Support Documents. HACCP. Appendix.