GAMP® Good Practice Guides Under Development

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Global Information Systems Control and Compliance

This GAMP Good Practice Guide is in the Planning Stage.

This Guide provides an understanding of the issues faced by teams that are tasked with completing a global deployment of an IT system, in particular, to provide some insight into addressing issues of control and regulatory compliance efficiently and effectively. The Guide encompasses a wide range of regulations and guidelines, including US FDA, EU GMPs, PIC/S Guidance, Health Canada GMP and ICH.

IT Infrastructure Control and Compliance

This GAMP Good Practice Guide is in the Planning Stage.

This Guide provide 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.

If you would like to submit a proposal for a Guidance document, please go to ISPE's Electronic Proposal Submissions.

For more information, contact ISPE at

ISPE Technical Document Draft KEY

Proposal: First stage of the Document Development Process which provides the Guidance Documents Committee (GDC) with sufficient information to determine if the proposed topic justifies an industry need to create a guidance document.

Document Plan: Second stage of the Document Development Process which contains a proposed Purpose and Objectives, Scope and Key Concepts, Structure (may include Outline), Team Organization with Core Team identified, Stakeholders, and Project Planning.

Outline: Made available online for the benefit of ISPE members to view the direction that a Task Team is taking in regard to a topic area. This also allows Members to indicate their willingness to participate in the development of a Guidance Document (where appropriate).

Executive Summary: Drafts of the introductory chapter(s), the regulatory chapter(s), descriptive outlines of other chapters, and titles of proposed appendices; developed to facilitate discussion of regulatory issues between task teams and regulatory agencies, as well as, to further illustrate the direction of the guidance document to Members.

Draft 1: First draft which includes main body of the document and drafts of all chapters and appendices (circa 80% to 90% complete). This draft is issued for industry review giving Members the opportunity to provide comment.

Draft 2: Final draft which includes all industry comments incorporated, as appropriate, and final technical edits completed. Proceeds to GDEC for review/approval, then fed into the ISPE Publication Process. If a Baseline® Guide, this draft is issued to the FDA for technical review prior to ISPE Publication Process.


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