PLANREFERENCE OUTLINE

Capital Project Charter & Business Case

Phase-0 charter template that captures the investment thesis, product and capacity basis, regulatory strategy, make-vs-buy decision, high-level quality criteria, and sponsor governance for a regulated capital project — the decision record every later phase traces back to.

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
ISPE Good Practice Guide: Project ManagementPMBOK Guide 7th ed.ICH Q10
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

The charter records why a regulated capital project exists, what it must deliver, and who owns the decision — the single reference every later design, qualification and change document traces back to. The failure is a charter stating cost and schedule but no quality criteria, which leaves the facility’s regulatory obligations to be discovered during design rather than set where money is committed.

What's Inside

✓Investment thesis and business case with quantified drivers, so later scope changes can be tested against it
✓Product, capacity and target-market basis that sizes the facility and fixes its regulatory exposure
✓Regulatory strategy summary naming the target markets and the frameworks the delivered facility must satisfy
✓Make-versus-buy and modality decision, with the rejected options and the reasoning behind rejection recorded
✓High-level quality criteria the delivered facility must meet, stated as acceptance rather than as aspiration
✓Governance model, sponsor sign-off, and the stage-gate structure every later gate review will reference
✓RACI matrix with an assumptions and risk register, including the assumptions that would invalidate the case

How to Use It

1Draft the investment thesis with finance and commercial before any engineering input, so the engineering answers a stated question
2Fix the target markets early — adding one after design freeze changes the qualification scope, not merely the paperwork
3Record the make-versus-buy decision including the options rejected, because a rejected option returns later as a change request
4State the high-level quality criteria as acceptance criteria; criteria written as aspirations cannot be verified at any gate
5Name the quality decision-maker for each gate, not only the project sponsor, well before the first gate arrives
6Place the charter under change control and revise it when the basis moves, rather than leaving it as history
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
1Business Case and Investment Thesis
2Product, Capacity, and Target-Market Basis
3Regulatory Strategy Summary
4Make-vs-Buy and Modality Decision
5High-Level Quality Criteria
6Governance and Sponsor Sign-Off
7RACI Matrix
8Assumptions and Risks
REGULATORY CONTEXT

The charter is a project-management artefact: PMBOK Guide 7th ed. and PRINCE2 frame charter and stage-gate practice, and the ISPE Good Practice Guide: Project Management applies it to regulated capital delivery. ICH Q10 sets the pharmaceutical quality system expectations the finished facility must satisfy. None of them prescribes your charter’s content or which quality criteria a given facility needs — that is the sponsor’s determination. Anchoring those criteria at phase zero is SPEQ synthesis.

MAPPED STANDARDS
ISPE Good Practice Guide: Project ManagementPMBOK Guide 7th ed.ICH Q10
Browse the standards catalog →