This is a Provision on packaging and labeling in a form consistent with the FDA QSR.
The FDA requires strict labeling controls.
In addition, UDI will become a QSR requirement in the future,
In addition, as the UDI becomes a QSR requirement, even stricter measures will be required for labeling.
List of Forms
The following forms are included with your purchase.
・Packaging and Labeling Management Provision
Table of Contents
2 scope (of a document)
3 Definition of Terms
4 Packaging Management
4.1 risk analysis
4.2 Creation of packaging material development procedures
4.3 Create packaging procedures for equipment
5.1 Labeling integrity
5.2 Inspection and storage of labels
5.3 serial number
5.4 labeling operation