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There are no Baseline Guides under development at this time.

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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