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.

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 — it states 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 is the project’s answer to "how is quality built in, not inspected in?"

What's Inside

✓Quality objectives and success criteria for the project

✓Roles, responsibilities, and the quality-unit’s decision authority (RACI)

✓Deliverables register with the regulated records identified

✓Stage-gate / quality-gate map and acceptance criteria

✓Quality risk-management approach (ICH Q9) and its link to the project risk register

✓Documentation and data-integrity (ALCOA+) strategy

How to Use It

1Issue a first version at concept, before the URS exists, and baseline it under change control

2Assign an owner to every deliverable and mark which are regulated records

3Embed the quality acceptance criteria inside each project stage gate

4Keep the quality and project risk registers in dialogue — reference one from the other

5Reissue at each phase boundary as scope, risks, and responsibilities are confirmed

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; ICH Q9(R1) provides the risk framework; and the ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry describes how GxP integrates with the project life cycle. The PQP is where those expectations become one operating document for the project.

MAPPED STANDARDS

ICH Q10ICH Q9(R1)ISPE GPG Project Management

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