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

chapter |6 pages


chapter 1|10 pages

Package Design Validation

chapter 2|34 pages

Package Process Validation

chapter 4|18 pages

Regulatory Activities