ISPE Good Practice Guide: Maintenance (Second Edition) cover image

ISPE Good Practice Guide: Maintenance (Second Edition)

Published:January 2021

Pages:132

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support. This Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program.

Since the first edition of this Guide, the ICH Q9 risk-based approach has been widely adopted worldwide. This edition reflects alignment with the risk-based approach with respect to maintenance and the pharmaceutical industry as a whole. Updates to this edition include consolidating basic and good practice categories, adding clarification on terminology for users, and updating examples.

  • 1 Introduction
  • 1.1 Background
  • 1.2 Purpose
  • 1.3 Scope
  • 1.4 Benefits
  • 1.5 Objectives
  • 1.6 Key Concepts
  • 1.7 Structure of the Guide
  • 2 Key Principles and Relationships
  • 2.1 Introduction
  • 2.2 Philosophy
  • 2.3 Maintenance Practices
  • 2.4 Maintenance Program
  • 2.4.1 Establishing a Maintenance Program
  • 2.4.2 Maintenance Plans
  • 2.4.3 Change Management
  • 2.4.4 Roles and Responsibilities
  • 2.4.5 Maintenance Documentation
  • 2.4.6 Equipment
  • 2.5 Spare Parts and Materials
  • 2.6 Training
  • 2.7 Culture
  • 2.8 Maintenance Key Relationships
  • 2.8.1 Safety
  • 2.8.2 Quality Management System
  • 2.8.3 Operations Management
  • 2.8.4 Equipment Reliability
  • 2.8.5 Physical Asset Management
  • 2.8.6 Risk Management
  • 3 Maintenance Good Practices and Maintenance Best Practices
  • 3.1 Introduction
  • 3.2 Overview
  • 3.3 Maintenance Good Practices
  • 3.4 Maintenance Best Practices
  • 3.4.1 Computerized Maintenance Management System
  • 3.4.2 Maintenance Subject Matter Experts
  • 3.4.3 Roles and Responsibilities
  • 3.4.4 Training Program
  • 3.4.5 Risk Assessment Process
  • 3.4.6 Reliability Assessment Process
  • 3.4.7 Predictive Maintenance and Condition Monitoring
  • 3.4.8 Maintenance throughout the System Lifecycle
  • 3.4.9 Maintenance Data and Documentation
  • 3.4.10 Proactive Maintenance Program Delivery
  • 4 Maintenance Program
  • 4.1 Overview
  • 4.2 Examples of Maintenance Program (Outline), Maintenance Strategy, and Maintenance Plan
  • 4.3 System Maintenance Strategy
  • 4.3.1 System Description
  • 4.3.2 System and Component Classification
  • 4.3.3 Science-Based Quality Risk Management
  • 4.3.4 Maintenance Tasks
  • 4.3.5 Intervals and Tolerances
  • 4.3.6 Spare Parts
  • 4.4 Maintenance Plan
  • 4.5 Types of Maintenance
  • 4.5.1 Purpose
  • 4.5.2 Proactive Maintenance Modes
  • 4.5.3 Reactive/Emergency Maintenance
  • 5 Maintenance Management
  • 5.1 Records for Facilities, Systems, and Equipment
  • 5.2 Labor Resources
  • 5.3 Planned Maintenance
  • 5.3.1 Preventive Maintenance
  • 5.3.2 Corrective Maintenance
  • 5.4 Spare Parts
  • 5.4.1 Like-for-Like or Functionally Equivalent Replacement Parts
  • 5.4.2 Controlling and Managing Spare Parts
  • 5.5 Paper-Based Maintenance Management Systems
  • 5.6 Computerized Maintenance Management Systems
  • 5.6.1 Paperless Systems
  • 5.6.2 Hybrid Systems
  • 5.7 Maintenance Documentation
  • 6 Work Execution
  • 6.1 Work Order Management
  • 6.1.1 Work Request
  • 6.1.2 Typical Work Request to Work Order Flowchart
  • 6.1.3 Information Requirements for Work Requests
  • 6.1.4 Work Order
  • 6.1.5 Information Requirements for Work Orders
  • 6.1.6 Planning and Scheduling
  • 6.1.7 Requirements for Planning and Scheduling
  • 6.1.8 Information Requirements for Planning and Scheduling
  • 6.1.9 Work Order Completion
  • 6.1.10 Information Requirements for Work Order Closure
  • 6.1.11 Work Order Information for KPI and Continual Improvement
  • 6.1.12 Emergency Work Management
  • 6.1.13 Typical Features of Emergency Work Processes
  • 6.1.14 Performance Measurement - Key Performance Indicators
  • 6.2 Self-Inspection and Continual Improvement
  • 6.2.1 Self-Inspection
  • 6.2.2 Continual Improvement
  • 6.3 Contract Management and Outsourcing
  • 6.3.1 Outsourcing Strategy
  • 6.3.2 Procedure for the Selection of Contractors/Outsource Organizations
  • 6.3.3 Engagement of Contract Maintenance Suppliers
  • 6.3.4 Performance Management
  • 6.4 Change Management
  • 6.4.1 Equipment/Facility Change Control/Notification
  • 6.4.2 Equipment Change Control Request
  • 7 Roles, Responsibilities, and Interfaces
  • 7.1 Introduction
  • 7.2 Roles and Responsibilities
  • 7.3 Production and Maintenance
  • 7.4 Project Engineering and Maintenance
  • 7.5 Health, Safety, and Environment and Maintenance
  • 7.6 Quality and Maintenance
  • 7.7 Organizational Structure
  • 8 Training
  • 8.1 Purpose
  • 8.2 Knowledge and Skills for Maintenance Personnel
  • 8.3 Training Scope and Curricula Management
  • 8.3.1 Training Scope
  • 8.3.2 Training Curriculum Management
  • 8.4 Training Methods and Trainers
  • 8.4.1 Training Methods
  • 8.4.2 Trainers and Instructors
  • 8.5 Training for Vendors, Contractors, and Consultants
  • 8.6 Training Effectiveness
  • 8.6.1 Possible Ways to Evaluate Training
  • 8.7 Training Record Keeping and Regulatory Requirements
  • 9 Appendix 1 - Regulatory Citations
  • 10 Appendix 2 - Health, Safety, and Environment in the Maintenance Environment
  • 10.1 Introduction
  • 10.2 HSE Program Management for the Maintenance Unit
  • 10.2.1 Management Support for the Program
  • 10.2.2 Supporting Processes
  • 10.2.3 Specific Considerations for Maintenance Risk Assessments
  • 10.2.4 5S and 6S
  • 10.2.5 Integration of HSE Into Maintenance Systems
  • 10.3 Hazards and Risk in the Maintenance Environment
  • 10.3.1 Hazard and Risk Agents
  • 10.3.2 Control and Mitigation of Hazard and Risk
  • 10.4 Control of Hazards and Risks in Maintenance Work Areas
  • 10.4.1 Handover and Hand Back of Facilities, Systems, and Equipment
  • 10.4.2 Conflict Between Safety and Product Quality
  • 10.4.3 Segregation of Work Areas
  • 10.4.4 Personal Protective Equipment
  • 10.4.5 Lone Working
  • 10.4.6 Transport of Materials
  • 10.5 Permit to Work System
  • 10.5.1 Key Features of a Permit to Work System
  • 10.5.2 Types of Permit to Work
  • 10.5.3 Applicability of the Permit to Work
  • 10.6 Control of Hazardous Energies, Lockout/Tagout
  • 10.6.1 Control of Hazardous Energies
  • 10.6.2 Lockout/Tagout
  • 10.7 Confined Spaces and Restricted Spaces
  • 10.8 Hot Work
  • 10.9 Flammable and Explosive Atmospheres
  • 10.10 Working at Heights
  • 10.11 Working with Compressed Gases
  • 10.12 Mandatory Maintenance Practices
  • 10.13 Facility Design for Maintenance Safety
  • 10.13.1 Maintenance Safety Considerations in Project Design Phase
  • 10.13.2 Changes to Systems
  • 10.14 Environmental
  • 10.14.1 Waste Management
  • 10.14.2 Energy Management
  • 10.14.3 Retirement and Decommissioning
  • 11 Appendix 3 - Science-Based Quality Risk Management
  • 11.1 Purpose
  • 11.2 Risk Management
  • 11.3 ICH Q9 Quality Risk Management Approach
  • 11.4 Overview of the Quality Risk Management Process
  • 11.5 Initiating Quality Risk Management
  • 11.6 Risk Assessment
  • 11.7 Risk Control
  • 11.8 Risk Communication
  • 11.9 Risk Review
  • 11.10 Quality Risk Management Tools
  • 12 Appendix 4 - Templates and Examples
  • 12.1 Example Scenarios
  • 12.2 Maintenance Strategy Template
  • 12.3 Example Maintenance Plan
  • 12.3.1 Example 1: Pump Rebuild PM
  • 12.3.2 Example 2: Cold Room Quarterly PM
  • 12.4 Example Maintenance Plan Checklist
  • 12.5 Example Change Control Request/Approval Form
  • 13 Appendix 5 - References
  • 14 Appendix 6 - Glossary
  • 14.1 Acronyms and Abbreviations
  • 14.2 Definitions
  • Dan Franklin, IPS, USA
  • Thomas Harris, AstraZeneca, USA
  • Michael Lacey, West Pharmaceutical Services, Ireland
  • Tim Lai, Boehringer Ingelheim, USA
  • Stephan Neumann, Boehringer Ingelheim GmbH, Germany
  • Peniel Ortega (Co-Lead), PharmAllies, USA
  • Constantino Rodriguez (Co-Lead), Catalent Cell & Gene Therapy, USA
  • Hamid Teimourian, AstraZeneca, USA
  • Alfred Ao Yu, Resilience Biotechnologies Inc., Canada

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance Programs have long been recognized as critical to the success of the operations they support.

This Guide focuses on achieving cost-effective compliance with existing regulations and associated guidance. It describes current established good practice and seeks to provide a practical and consistent interpretation of the required elements of a pharmaceutical Maintenance Program, while offering maximum flexibility to enable widespread adaptation and encourage innovation.

This Guide focuses on maintenance in GMP areas and is intended to be used as a tool for the development, implementation, and execution of a Maintenance Program in a pharmaceutical manufacturing environment.

Since the first edition of this Guide, the ICH Q9 risk-based approach has been widely adopted worldwide. This edition reflects alignment with the risk-based approach with respect to maintenance and the industry as a whole. Updates to this edition include consolidating basic and good practices categories, adding clarification on terminology for users, and updating examples.