PLANREFERENCE OUTLINE

Project Quality Plan (PQP)

The single document that defines how quality is built into a regulated project — quality objectives, roles and responsibilities, deliverables and gates, risk-management approach, and the documentation strategy — from concept through commercial release. Maps to ICH Q10, ICH Q9(R1), and ISPE Good Practice Guide: Project Management.

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
ICH Q10ICH Q9(R1)ISPE GPG Project Management
DOCUMENT TYPE
Plan
LAST UPDATED
July 2026
PURPOSE

The controlling document for quality on a regulated project: the quality objectives, who owns what, which deliverables are regulated records, how risk is managed, and how quality is assured at every gate from concept to commercial release. It answers how quality is built in rather than inspected in. Which deliverables count as regulated records on your project is your determination, and getting it wrong late is expensive.

What's Inside

✓Quality objectives and success criteria stated so a gate reviewer can judge them, not admire them
✓Roles, responsibilities and the quality unit’s decision authority, including where it can stop the project
✓Deliverables register marking which items are regulated records and naming who owns each one
✓Stage-gate and quality-gate map with the acceptance criteria attached to each individual gate
✓Quality risk-management approach under ICH Q9(R1), linked to the project risk register both ways
✓Documentation and data-integrity strategy, including ALCOA+ expectations for records the project generates
✓Handover, closure and lessons-learned, so the plan ends in an operations handover rather than silence

How to Use It

1Issue a first version at concept, before the requirements exist, and baseline it under change control.
2Assign an owner to every deliverable and mark the regulated records; an unmarked regulated record is generated without controls.
3Embed the quality acceptance criteria inside each stage gate rather than holding them in a separate quality schedule.
4Keep the quality and project risk registers in dialogue; two registers that never reference each other diverge within a phase.
5Reissue at each phase boundary as scope, risks and responsibilities are confirmed, and record what changed.
6Close the plan through a documented handover to operations, naming who now owns each surviving quality commitment.
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
1Purpose, Scope, and Project Overview
2Quality Objectives and Success Criteria
3Organisation, Roles, Responsibilities, and Decision Authority
4Regulatory Strategy and Applicable Standards
5Deliverables Register and Records Identification
6Stage Gates, Quality Gates, and Acceptance Criteria
7Quality Risk Management Approach (ICH Q9)
8Change Control and Change Management Interface
9Documentation and Data-Integrity Strategy (ALCOA+)
10Handover, Closure, and Lessons-Learned
REGULATORY CONTEXT

ICH Q10 expects quality to be managed across the product lifecycle with management responsibility defined, ICH Q9(R1) provides the risk framework the plan applies, and the ISPE Good Practice Guide: Project Management describes how GxP integrates with a project life cycle. None of them defines your gates, your deliverables register, or which project records your quality system will treat as regulated — the plan is where your organisation makes those choices explicit and reviewable. The consolidated structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
ICH Q10ICH Q9(R1)ISPE GPG Project Management
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