Supply Chain Resiliency Plan (Attachment 0001 to Contract Data Requirements)
The contractor shall provide a comprehensive Supply Chain Resiliency Plan that provides for identification and reporting of critical components associated with the secure supply of drug substance, drug product, and work-in-process through to finished goods.
1. A critical component is defined as any material that is essential to the product or the manufacturing process associated with that product. Included in the definition are consumables and disposables associated with manufacturing. NOT included in the definition are facility and capital equipment.
Consideration of critical components includes the evaluation and potential impact of raw materials, excipients, active ingredients, substances. pieces, parts, software, firmware, labeling, assembly, testing, analytical and environmental componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks, seed stocks, devices and key processing components and equipment. A clear example of a critical component is one where a sole supplier is utilized.
2. The contractor shall identify key equipment suppliers, their locations, local resources, and the associated control processes at the time of award. This document shall address planning and scheduling for active pharmaceutical ingredients, upstream, downstream, component assembly, finished drug product and delivery events as necessary for the delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or as necessary, as part of regular contractual communications.
b) For upstream and downstream processing, both single-use and re-usable in-place processing equipment, and manufacturing disposables also shall be addressed. For finished goods, the inspection, labeling, packaging, and associated machinery shall be addressed taking into account capacity capabilities.
c) The focus on the aspects of resiliency shall be on critical components and aspects of complying with the contractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreign sourced, both high and low volume, which would significantly affect throughput and adherence to the contractually agreed deliveries.
3. The contractor shall articulate in the plan, the methodology for inventory control, production planning, scheduling processes and ordering mechanisms, as part of those agreed deliveries.
a) Production rates and lead times shall be understood and communicated to the HHS/ASPR/BARDA Contracting Officer or the Contracting Officer’s Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by design, and communicated to contractual personnel. As necessary, communication should focus on identification, exploitation, elevation, and secondary constraints of throughput, as appropriate.
4. Reports for critical items should include the following information:
a) Critical Material
b) Primary vendor and secondary vendor, if applicable
c) Supplier, Manufacturing / Distribution Location
d) Supplier Lead Time
e) Shelf Life
f) Transportation / Shipping restrictions
g) Comparability studies, if applicable
h) Amount of material (dose equivalent) in inventory