ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 09/01/2005

Full Description

The validated status of GxP applications that are dependent upon an underlying IT Infrastructure is compromised if that IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. The consequences of the IT Infrastructure being out of effective control can be significant. Depending on the nature of a failure, an entire site or geographic region of operations could be brought to a standstill while the problem is resolved.

The GAMP GPG: IT Infrastructure Control and Compliance provides comprehensive guidance on meeting current regulatory expectations for compliant IT Infrastructure platforms, including the need to identify, qualify, and control those aspects impacted by GxP. The Guide includes the description of a scaleable qualification framework which has been derived from key principles and practices. It describes how this framework can be applied to different platform types in order to determine the extent and scope of qualification efforts.

This Guide covers a range of IT Infrastructures, from those found in companies operating globally to isolated or semi-isolated GxP regulated infrastructures. Key aspects considered include: installation and operational qualification of infrastructure componentsconfiguration management and change control of infrastructure components and settings in a highly dynamic environmentmanagement of risks to IT Infrastructureinvolvement of service providers in critical infrastructure processessecurity management in relation to access controls, availability of services and data integritybackup, restore, and disaster recoveryarchiving

To avoid unnecessary effort, this Guide describes a horizontal, or platform based, approach.

Benefits of this horizontal approach include: higher level of standardization throughout the entire life cycle minimal overlap in documentationminimal overlap in qualificationminimal overlap in audits, inspections, and assessments

The Guide is intended primarily for regulated life science industries, including pharmaceutical, biological, and medical devices, but also provides valuable information for suppliers of systems, products, or services. This Guide also may prove useful to managers of IT Infrastructures which are not regulated by GxP.

This GAMP GPG: IT Infrastructure Control and Compliance has been designed so that it may be used in conjunction with guidance provided in GAMP 4 and other ISPE publications.

Product Details

Published: 09/01/2005 ISBN(s): 1931879427 Number of Pages: 128