Barnhardt – JA – 835
This Rx-360 Audit Report contains the following scope:
The scope of the audit included the manufacture, packaging, testing and distribution of
packaging materials used for purposes of packaging of products particularly pertaining to
Poly-Coil 9 GM.
The audit was based on Rx-360 Guideline for Pharmaceutical Packaging Materials for
Medicinal Products, V 1.0 and the Rx-360 Supply Chain Security Checklist 2.0.