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ISPE Good Practice Guide: Management of Engineering Standards cover image

ISPE Good Practice Guide: Management of Engineering Standards

Published:August 2016

Pages:52

The ISPE Good Practice Guide: Management of Engineering Standards aims to provide a common understanding and approach to the management of Engineering Standards. It is based on industry best practices and developed with input from several peer organizations. The Guide addresses the knowledge management needs associated with the identification of content, creation, review, and approval of Engineering Standards.

The ISPE Good Practice Guide: Management of Engineering Standards provides guidance on how to establish and maintain an Engineering Standards Program. It covers the entire lifecycle of an Engineering Standard, from chartering to retirement. In addition, it includes a description of the governance process for the Engineering Standards Program.

Several templates and examples are provided separately in MS Word for use by readers within their organizations.

This Guide is a unique opportunity to consolidate, into a single document, the complex body of knowledge involved with Engineering Standards in the highly regulated pharmaceutical industry. It is intended for established engineering standards program, or if you are looking to change or develop one. In addition, this Guide addresses the process of keeping content current and compliant through periodic review and successful integration with third party designers/integrators.

Key benefits of having an Engineering Standards Program include:

  • Streamlining of the engineering information gathering processes by providing a compliance roadmap for engineers to follow
  • Providing an effective knowledge capture and dissemination process (Knowledge Management System) that is integrated into the engineering process
  • Assuring the appropriate level of quality, safety, and regulatory compliance is incorporated into engineering designs
  • Reducing costs and time to conceptualize, engineer, specify, design, commission, and qualify engineering solutions

The ISPE Good Practice Guide: Management of Engineering Standards is written for engineering standards programs, but the principles also apply to other guidance documents including ISPE Guidance Documents, International Council for Harmonisation (ICH) guidelines, and industry recognized standards.

  • 1 Introduction and Business Value
  • 1.1 Business Value
  • 1.2 Relationship to Other Documents
  • 1.3 Program Foundational Principles
  • 1.4 Governance Body
  • 1.4.1 How Standards Apply to Existing Systems or a Project in Implementation
  • 1.5 Variances
  • 1.6 Review Cycle
  • 2 Key Terms/Document Types
  • 3 Operating Principles
  • 3.1 Steering Committee Meeting Logistics Principles
  • 3.2 Document Principles
  • 4 Engineering Standards Program Governance
  • 4.1 Sponsor
  • 4.2 Steering Committee
  • 4.3 Program Manager
  • 4.4 Design of Documents
  • 4.5 Document Owner
  • 4.6 Subject Matter Expert
  • 5 Creating and Approving Document Content
  • 5.1 Document Development Process
  • 5.2 Planning
  • 5.2.1 Screening Process
  • 5.2.2 Chartering a Topic
  • 5.3 Authoring/Development/Review
  • 5.3.1 Creating or Revising Document Content
  • 5.3.2 Technical and Editorial Review
  • 5.4 Approval
  • 6 Document Maintenance
  • 6.1 Periodic Review
  • 6.2 Management System
  • 6.3 Revision Management
  • 6.4 Retiring Documents
  • 7 Knowledge Transfer
  • 7.1 Communication
  • 7.2 Training
  • 8 Engineering Standard Variance Process
  • 9 Partner Firm Use of Operating Company Engineering Standards
  • 9.1 Introduction and Overview
  • 9.2 Applicability of Engineering Standards to Partner Firms
  • 9.3 Transmittal of Engineering Standards
  • 9.4 Partner Firm Use of Engineering Standards
  • 9.5 User Requirements Specifications in Relationship to Engineering Standards
  • 10 Appendix 1 - Templates and Examples
  • 10.1 Engineering Document Project Charter Template
  • 10.2 Generic Standard Template
  • 10.3 Document Comment Summary
  • 10.4 Example Governing Board Presentation Slides
  • 10.5 Applicability Grid Project Example
  • 10.6 Engineering Standard Variance Request
  • 11 Appendix 2 - Acronyms
  • Jonathan Becker, RPA Engineering, USA
  • Christopher Derrett, Tintern Tech, United Kingdom
  • Jeffrey S. Fluharty (Co-Lead), Eli Lilly and Co., USA
  • Bryan W. Fluke, RPA Engineering, USA
  • Jacqueline Glanville, Abbott Laboratories, USA
  • Francesca A. McBride, Jacobs Engineering, USA
  • Duane A. Mowrey, Eli Lilly and Co., USA
  • Frank J. Smith (Co-Lead), Merck & Co., Inc., USA
  • Joseph P. Wegrzyn, Abbott Laboratories, USA

This ISPE Good Practice Guide on the Management of Engineering Standards has been developed and published by ISPE with the aim to provide to the industry a common understanding and approach to the management of Engineering requirements (Standards) typically set at the corporate level for manufactures, designers, and builders of Pharmaceutical plants and processes. This Guide is a unique opportunity to integrate in a single document the complex body of knowledge required by all professionals involved in the highly regulated pharmaceutical market.

The Guide is intended to promote excellence and knowledge within the pharmaceutical Engineering enterprise and systems. The Guide addresses the knowledge management needs associated with the identification of content, creation, review and approval of Engineering Standards. In addition, the process of keeping content current and compliant through periodic review, as well as successful integration with third party designers/integrators are also addressed.

The Guide is a reference source of good practices covering in a structured way a wide variety of themes, subjects, problems and issues faced across the realm of pharmaceutical design, maintenance, and operation. This Guide is intended to be read in conjunction with other ISPE guidance, International Council for Harmonisation (ICH) guidelines, and industry recognized standards.