![ISPE GAMP<sup>®</sup> Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach [Chinese Translation] cover image](/cms/asset/3e0985c1-1cee-4fcb-85c3-a493e50f00ee/9781936379798.cover.jpg)
ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach [Chinese Translation]
Published:February 2014
Pages:116
The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline.
No Acknowledgments available
The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach, was created to help to facilitate the planning, development, and testing of Manufacturing Execution Systems (MES) that may be used to support manufacturing in life sciences organizations.
This Guide is intended to help bridge the gap between the ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance and the ISPE GAMP® Good Practice Guide: Validation of Process Control Systems for supporting and maintaining MES environments. The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach should be read in conjunction with these Guides.
GAMP® guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. This Guide has been developed by pharmaceutical industry professionals to meet these goals and principles.
This Guide takes a life cycle approach to examining MES, not as an application, but as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization.
As individual systems evolve to become broader in scope, a system considered to be business-oriented may have functionality which connects to Manufacturing Operations and potentially affects product quality. Therefore, the integration of functions may require the application of testing principles for process control systems to a system considered to be business-oriented. The definition of a ‘business system’ may become difficult, and it may become necessary to create logical boundaries around functionality across systems to define categories of use and criticality.
The domain approach presented in this Guide provides an approach to manage life cycles for the integrated manufacturing environment.
The authors of this Guide have built upon ANSI/ISA 95.00.01-2000, Enterprise-Control System Integration, Part 1; Models and Terminology, an industry independent standard for improved integration of manufacturing through communication that defines common terminology and a consistent set of models that emphasize good practices for integration of control systems with other enterprise systems.