For more information, contact ISPE at 1-813-960-2105, or Ask@ispe.org
The first draft of this Guide has been issued for industry review and comment. The concepts presented in this Guide reflect the current industry facility design thinking with a full focus on product protection via closed processing and the resultant possibilities to simplify the facility design – essentially, if all processes are fully closed, to a single Controlled Non-Classified (CNC) production ballroom. This concept is a significant paradigm shift for facility designs for the biopharm industry.
For additional information on the structure of the Guide revision and outline, please download the overview.
The Document Team appreciates your comments and views on the facility concepts presented in this Guide. To request a copy of the draft and comment form, please send your contact information to: Guides@ISPE.org. The review deadline is 30 November 2012.
Draft 2 of the ISPE Guide: Biopharmaceutical Process Development and Manufacturing is undergoing final edit in preparation for GDEC review.
This Guide will focus on the scope of work involved in product and process development and manufacturing for biopharmaceuticals. Areas to be covered will include Quality by Design, general biopharmaceutical processes, upstream and downstream processing, process support and utilities, scale-up, and tech transfer.
This new Guide is in Draft 1 development.
This Guide will cover development of cleaning processes, cleaning validation, and use of statistics in cleaning validation and PAT. Key components are:
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)
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.