There are currently no Baseline Guides under development at this time.
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 Ask@ispe.org
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.