17-75A50126R00001_RFP Att 17 Manufacturing Plan.pdf
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- Solicitation number
- 75A50126R00001_RFP_NPIVS_27
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This is a contract clause establishing requirements for a comprehensive Manufacturing Plan that must be developed, maintained, and submitted by the Contractor for pharmaceutical or biotechnology products under federal contract.
The Contractor must submit an initial Manufacturing Plan by the date specified in the Deliverable Table and provide updates prior to scheduled gated reviews, option exercises, significant manufacturing scale advancements, technology transfers, pivotal study material production, or regulatory submissions containing substantive Chemistry, Manufacturing, and Controls (CMC) details. The Contractor must notify the Contracting Officer's Representative (COR) immediately upon identifying material changes affecting manufacturing, including changes to manufacturing sites, service providers, processes, raw materials, components, suppliers, scales, formulations, container closure systems, analytical methods, control strategies, release specifications, stability strategies, technology transfer plans, or production schedules. Unless an earlier due date is established, material changes must be included in the next Manufacturing Plan submission.
The Manufacturing Plan must address administrative information and revision history, product overview, development stage and manufacturing maturity, manufacturing process overview, drug substance and bulk drug substance manufacturing information, drug product manufacturing information, control strategy and analytical methods, container closure and packaging specifications, stability and shelf life data, components and services, manufacturing readiness and technology transfer, production schedules and capacity, manufacturing risks and mitigation strategies, and changes since prior submission. A Bill of Materials (BOM) must be submitted as an attachment using the BARDA BOM template or equivalent format acceptable to the Contracting Officer, identifying component sources, locations, availability, quantities, storage requirements, shelf life, shipping details, and supplier information. The level of detail must correspond to the product development stage, with early-stage submissions permitted to include preliminary information that must be replaced with established CMC data as the product advances. The Manufacturing Plan content must align with FDA Current Good Manufacturing Practice (CGMP) regulations and relevant International Council for Harmonisation quality guidance. Submission templates for both the Manufacturing Plan and BOM are available upon request.
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Manufacturing Plan Clause - v202606
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.
The Manufacturing Plan must identify components and services associated with the product, the manufacturing process, or testing associated with the product, to the extent established, planned, or reasonably available for the applicable development stage. A component is defined as any material that is required for the product, the manufacturing process, or testing associated with that product. Included in the definition are consumables and disposables associated with manufacturing. Not included in the definition are facilities and capital equipment. Services must be described in the Manufacturing Plan, including each relevant in house, contracted, or subcontracted capability, service provider legal entity, physical location, country, role or activity performed, relationship to the Contractor, development or manufacturing stage supported, and current or planned status.
The Contractor must submit the bill of materials (BOM) as an attachment to the Manufacturing Plan using the BARDA BOM template or an equivalent format acceptable to the CO, in
Manufacturing Plan Clause - v202606 consultation with the COR. The BOM must identify components associated with the product, the manufacturing process, or testing associated with the product, including source, location, availability, quantity, storage, shelf life, shipping, and related supplier, distributor, or manufacturer information to the extent established, planned, or reasonably available for the applicable development stage.
The level of detail must correspond to the product development stage and manufacturing maturity. For early development, the Contractor may provide preliminary, planned, or not yet established information. As the product advances, subsequent Manufacturing Plan submissions must replace preliminary information with available established CMC information.
The Contractor must align the content of the Manufacturing Plan, as applicable to product type and development stage, with United States Food and Drug Administration (FDA) Current Good Manufacturing Practice (CGMP) regulations and relevant International Council for Harmonisation quality guidance addressing pharmaceutical development, quality risk management, pharmaceutical quality systems, drug substance development and manufacture, analytical procedures, stability, and process validation.
The Manufacturing Plan may be organized using the Contractor’s existing CMC structure, development stage terminology, clinical phase terminology, manufacturing readiness terminology, or another format acceptable to the CO, in consultation with the COR, provided the information required by this clause is addressed.
Submission templates for both the Manufacturing Plan and BOM are available upon request.
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