Baseline Guides Under Development

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Oral Solid Dosage Forms

This third edition is intended to help drive standardization, consistency, efficiency, and cost reduction in new and renovated OSD manufacturing facilities. The Team is currently working on Draft 1.

Science and Risk-Based Cleaning Process Development and Validation

Draft 1 of this Guide has completed external industry review and the Team is working through comments.

This Guide will cover development of cleaning processes, cleaning validation, and use of statistics in cleaning validation and PAT. Key components are:

  • Cleaning Process Development
  • Cleanability Studies
  • Health Based Safety Thresholds
  • Cleaning Failure Modes and Effects Analysis
  • Cleaning Process Performance Capability.

These activities develop scientific knowledge of cleaning processes and are ultimately linked to the protection of the patient.

Now available: Overview of the New ISPE Cleaning Guide ( 416 KB)

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.

Last Update: 03 March 2014


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