PI 054-1 - Recommendation - How to Evaluate and Demonstrate Effectiveness of a Pharmaceutical Quality System in Risk-based Change Management

Sep 12, 2026

Guidance for GMP inspectors on evaluating and demonstrating the effectiveness of a company’s pharmaceutical quality system (PQS) with respect to risk-based change management. The text explains how inspectors can assess each stage of the change process, including change proposal, change assessment, change planning and implementation, and change review with effectiveness checks. It clarifies that the described aspects reflect typical practice and connect with PIC/S GMP Guide expectations for documenting PQS effectiveness and applying quality risk management principles.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages9

Reading Time3 min

AccessFree to download

Document history

Introduction

Practical guidance for GMP inspectors

Relationship to typical change management practice

Purpose

PQS effectiveness and planned changes per PIC/S GMP Guide

Control of change and quality risk management via PIC/S guidance

What Section 5 addresses

Guidance

Revision history

Appendices

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 054-1 2 Appendices 15 July 2021 RECOMMENDATION How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management © PIC/S 2021 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat e-mail: [info@picscheme.org](info@picscheme.org) web site: [https://www.picscheme.org](https://www.picscheme.org) TABLE OF CONTENTS page 1. Document history 2 2. Introduction 2 3. Purpose 2 4. Scope 4 5. Guidance 4 6. Revision history 8 Appendices 9 1. Document History | Adoption by Committee of PI 054-1 | 30 June 2021 | | --- | --- | | Entry into force of PI 054-1 | 15 July 2021 | 2. Introduction 2.1. This document provides practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s pharmaceutical quality system (PQS) in relation to risk-based change management. It covers all relevant steps in the change management process – change proposal, change assessment, change planning and implementation, change review and effectiveness checks. It indicates within each step the aspects that render the PQS to be effective in that area. 2.2. Note: These aspects are in accordance with the considerations that are already typical and commonly applied in a change management process; they do not introduce any new GMP requirement. 2.3. Other useful guidance for GMP Inspectors in relation to change management is provided in the PIC/S Aide Memoire on QRM Implementation. 3. Purpose 3.1. The purpose of this document is to provide guidance on evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management as are governed by the PIC/S GMP Guide. This is in recognition of the fact that the PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. 3.2. It is useful to note that Chapter 1 of the PIC/S GMP Guide states the following in relation to PQS effectiveness and planned changes: 􀁸 Principle: ‘ there must be ‘a comprehensively designed and correctly implemented PQS incorporating GMP and QRM. It should be fully documented and its effectiveness monitored’. 􀁸 Section 1.3 ...’the effectiveness of the system is normally demonstrated at the site level’. 􀁸 Section 1.5 ‘Senior management has the ultimate responsibility to ensure an effective PQS is in place...’ 􀁸 Section 1.4 (xii) Arrangements [should be] in place ‘for the prospective evaluation of planned changes and their approval prior to implementation ’ 3.3. In relation to change management, Annex 15 of the PIC/S GMP Guide states: 􀁸 Section 11.1. ‘The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system.’ 􀁸 Section 11.4. ‘Quality risk management should be used to evaluate planned changes and to plan for any necessary process validation, verification or requalification efforts.’ 􀁸 Section 11.7. ‘ an evaluation of the effectiveness of change should be carried out ’ 3.4. The guidance in Section 5 of this document addresses the following points: 􀁸 The key elements that could be included in risk-based change proposals. 􀁸 The assessment by the pharmaceutical manufacturer of change proposals from a risk perspective, where: o the level of rigor, effort and documentation is commensurate with the level of risk, o the risk assessments adequately evaluate the potential risks and benefits of changes to product quality, safety and efficacy, and o those risk assessments consider the potential risks and benefits to other products, processes and systems. 􀁸 The classification by the pharmaceutical manufacturer of changes based on the level of ris

FAQs

What is the main objective of PI 054-1?

To provide guidance for evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management, aligned with expectations in the PIC/S GMP Guide.

Which stages of the change management process does the document cover?

It covers the full process, including change proposal, change assessment, change planning and implementation, and change review with effectiveness checks.

Does the guidance create new GMP requirements?

No. The aspects described align with considerations already typical in change management and do not introduce new GMP requirements.

Sep 12, 2026

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