Baseline Guides Under Development

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Active Pharmaceutical Ingredients (Third Edition)

This Guide is in the planning stage.

This revision builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients—originally entitled Bulk Pharmaceutical Chemicals. The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance, such as:

  • ICH Q7
  • ICH Q9
  • GAMP 4
  • 21 CFR Part 11
  • Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP)
  • FDA Draft Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

Oral Solid Dosage Forms (Third Edition)

Draft 2 is near completion and GDC review is planned for first quarter 2015.

This third edition is intended to help drive standardization, consistency, efficiency, and cost reduction in new and renovated OSD manufacturing facilities.

Sterile Product Manufacturing Facilities (Third Edition)

Draft 1 of this Baseline Guide is in development.

The Sterile Product Manufacturing Facilities Baseline® Guide addresses the design, construction, commissioning, and qualification of facilities designed for aseptic processing of formulated products. The Guide is designed for use by industry for the design, construction, commissioning, and qualification of new or renovated aseptic/sterile manufacturing facilities.

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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