ASTM International
Standards
Digital Library
Books && Journals
Technical Committees
Membership
Meetings
Symposia
Training Courses
Proficiency Testing
Equipment
Lab Directory
Consultants Directory
About ASTM
Magazines && Newsletters
Newsroom && Information
StudentMember
global
Product Information
Get Product Updates
Request A Free Catalog
View Catalog
Standardization News Search
LoginSite MapOnline SupportContactPrivacy PolicyIP Policy
Site Search
 

         Bookmark and Share
View
Shopping Cart

Magazines & Newsletters / ASTM Standardization News

ASTM International - Magazines & Newsletters/Standardization News/Feature
Contents | Standards Actions | Advertisers | Masthead | SN Archive
Rate Card | Subscriptions | Meetings Calendar | Talk to the Editor
Standards Search | Technical Committees | News & Info | Site Map | ASTM Contacts
FREE Sample Magazine (Type Mailing Address into E-mail Message) | President's Column Archive
 March 2007
Tech News

Process Analytical Technology Committee Approves First Practice

ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has approved its first practice. ASTM E 2474, Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice.

Practice E 2474 covers process design, which is integral to process development as well as post-development process organization. In the context of E 2474, process design refers both to the activities involved in designing a process and the outcome of the activity. E 2474 describes practices that should be considered to design effective and efficient pharmaceutical manufacturing processes that ensure product quality and performance.

Gerd Fischer, member of Committee E55 and director, industrial quality and compliance, Sanofi-Aventis, says that the Process Analytical Technology guidance published by the U.S. Food and Drug Administration in 2004 introduces PAT as a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance. E 2474 outlines scientific principles and tools that support process design in a PAT environment, and that are suitable to facilitate innovation and risk-based decisions.

“E 2474 will help to focus process design and development on science- and risk-based design strategies to manage variation,” says Fischer. “Integration of PAT principles and tools during process design will enhance opportunities to build, maintain and expand science- and risk-based process understanding throughout a product’s life cycle.”

Because process design is such an important part of the development process, as well as post-development process optimization, Fischer notes that the main users of E 2474 will be pharmaceutical process developers, manufacturers and quality assurance workers.

CONTACT:

Technical Information: Gerd Fischer
Sanofi-Aventis, Frankfurt, Germany
Phone: +49 69 305 17932

ASTM staff: Pat Picariello
Phone: 610/832-9720

Upcoming Meeting: May 22-24
May Committee Week
Norfolk, Va.

 
Site Map | Online Support | Contact | Web Policies | IP Policy
Copyright © 1996-2007 ASTM. All Rights Reserved.
ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA