Purpose and Scope:
This white paper reviews the present state, current challenges, and recommended best practices for several upstream supply chain security topics. The “upstream supply chain” refers to any part of the supply chain prior to drug product manufacturing. This white paper covers the following topics:
● Supply Chain Security Awareness
● Supply Chain Mapping
● Risk Assessment Tools and Risk Assessment Approaches
● Intended Use and Documentation
● Supplier Questionnaires / Surveys
● Change Control and Change Notification
This paper was developed from a survey (“The Survey”) sent to the Rx-360 membership. Rx-360 members were surveyed on a variety of topics. The results are collated in Appendix 1.
This white paper will address 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 will also discuss 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.
Introduction and Background:
The Drug Quality and Security Act, or “Drug Supply Chain Security Act”, was signed into law on November 27, 2013. This act will be phased in over the next 10 years and will include requirements for product identification, tracing, verification, detection and response, notification systems, wholesaler licensing, and third-party-logistics-provider licensing. However, to date no pedigree requirements for upstream supply chain security have been implemented.
The Rx-360 Upstream Supply Chain Security working group was formed in June 2013. The working group created and subsequently sent out a survey in August 2013 to poll the Rx-360 membership regarding upstream Supply Chain Security (SCS) issues. The Survey was developed to understand industry concerns related to upstream supply chain security. The Survey included a high level overview of the key areas addressed within upstream supply chain security processes.
Thirty-four Rx-360 members responded to the survey. Approximately half of respondents were pharmaceutical suppliers and half were pharmaceutical manufacturers. Respondents included large pharmaceutical manufacturing companies, small pharmaceutical manufacturing companies, biopharmaceutical manufacturers, raw material manufacturers and suppliers. The respondents represented over 80% of the largest global pharmaceutical companies by revenue.