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Upstream Supply Chain Security Risk Assessment Tool


This tool has been developed in excel document:

  • Tab 1: Cause and Effect Matrix
  • Tab 2: Failure Mode and Effects Analysis.

Background of Template:

The template was designed to compliment the Upstream Supply Chain Security . This white paper addresses pharmaceutical raw materials (Active Pharmaceutical Ingredients (APIs), excipients), starting materials for APIs and excipients, process materials, primary direct contact materials (bags, filters, tubing), and primary packaging materials. This white paper also discusses parties involved in the chain of custody or GxP services (i.e., sterilizers, contract lab services, warehouses, and logistics (including 3rd-party providers)).

This white paper will not discuss medical devices and secondary packaging materials. This white paper will also not discuss facilities services, including maintenance, housekeeping, and pest control.

We recommend downloading the white paper to help you give context into the template and better maximize your success!