Request for Proposals Attachment 17 Manufacturing Plan

ATTACHMENT 17

Manufacturing Plan
The Contractor must develop, maintain, and submit a comprehensive Manufacturing Plan tailored to the product type, development stage, funded activities, manufacturing maturity, and available Chemistry, Manufacturing, and Controls (CMC) information. The initial Manufacturing Plan is due at the time specified in the Deliverable Table. If the current Manufacturing Plan does not adequately incorporate information required for a scheduled gated review, option exercise, significant funded manufacturing scale advancement, technology transfer, production of pivotal study material, or a planned submission containing substantive CMC details, the Contractor must provide an updated Manufacturing Plan prior to the activity. This update must be submitted by the deadline outlined in the Contract, Statement of Work, or as directed in writing by the Contracting Officer (CO) in consultation with the Contracting Officer’s Representative (COR).
The Contractor must notify the COR after identifying a material change affecting the accuracy of the Manufacturing Plan. A material change includes, but is not limited to, a change in manufacturing site, service provider, manufacturing process, critical raw material, component, supplier, distributor, manufacturer, scale, formulation, container closure system, analytical method, control strategy, release specification, stability strategy, technology transfer plan, production schedule, or any change that could affect product quality, availability, regulatory strategy, cost, schedule, manufacturing supply chain visibility, or manufacturing readiness. Unless established as an earlier due date, the Contractor must include the material change in the next Manufacturing Plan submission.
The Manufacturing Plan must include, to the extent established, planned, or reasonably available for the applicable development stage: administrative information and revision history; product overview; development stage and manufacturing maturity; manufacturing process overview; drug substance manufacturing information; bulk drug substance manufacturing information; drug product manufacturing information; control strategy and analytical methods; container closure, packaging, labeling, and presentation; stability, storage, and shelf life; components and services; manufacturing readiness, scale advancement, and technology transfer; production schedule and capacity for the funded work; manufacturing risks, constraints, and mitigation; and manufacturing changes since prior submission.