PLANREFERENCE OUTLINE

Basis of Design (BoD)

Front-end-planning template that fixes the design basis — capacity, product mix, quality targets, regulatory and standards basis, process/utility basis, classification concept, contracting model, and cost/schedule class — so detailed design proceeds from an agreed, change-controlled baseline.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)EU GMP Annex 1 (2022)21 CFR Part 211
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

The document that fixes the technical, regulatory and commercial basis detailed design must satisfy, while changing it still costs a meeting rather than a demolition. It fails when written as a wish list with no assumptions register, so every unresolved question is rediscovered during construction as a change order. Which markets the facility will supply is a commercial determination this document forces the organisation to make early.

What's Inside

✓Design-basis inputs — capacity, product mix and quality targets — traced to the approved project charter
✓Regulatory and standards basis stated per intended market, because markets added later arrive as rework
✓Process design basis with the unit operations, materials of construction and throughput assumptions named
✓Clean and black utility design basis tables, sized against the process rather than against precedent
✓Cleanroom classification and segregation concept, set at the point where changing it is still cheap
✓Delivery and contracting model with the vendor documentation that later verification will depend on
✓Assumptions register with owners and closure dates, so an assumption cannot outlive the design stage

How to Use It

1Populate the design-basis inputs from the approved charter, and escalate any input the charter does not actually settle
2Fix the regulatory and standards basis for every intended market now; a market added after design is a rework programme
3Define the process, utility and segregation concepts with the subject-matter experts who will operate them, not only with designers
4Set the contracting model and the vendor documentation requirements that commissioning and qualification will later rely on as evidence
5Record every assumption with an owner and a closure date; an unowned assumption becomes a construction-phase change order
6Baseline the document under change control before detailed design starts, and route later changes through that control rather than by email
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Design-Basis Inputs
2Regulatory and Standards Basis
3Process and Utility Design Basis
› Process design basis› Utility design basis
4Classification and Segregation Concept
5Delivery Model and Vendor-Documentation Requirements
6Cost and Schedule Class Basis
7Assumptions Register
8Baseline Control and Approvals
REGULATORY CONTEXT

ASTM E2500-25 and the ISPE Baseline Guide Vol. 5 (2nd ed.) make requirements definition the foundation of science- and risk-based verification, and the Basis of Design is where those requirements first take engineering form. The classification and segregation concept applies EU GMP Annex 1 (2022) contamination-control thinking at its cheapest point to change, and 21 CFR Part 211 sets the facility expectations for a US-supplying site. What capacity, product mix and markets you design for is your commercial determination.

MAPPED STANDARDS
ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)EU GMP Annex 1 (2022)21 CFR Part 211
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