IHS Inc. The Source for Critical Information and Insight
All Industries |  Change  

Go
 
 

ASTM Int'l Releases Pharmaceutical Verification Standard - ASTM E 2537

April 3, 2008 // Published as a news service by IHS

 
IHS Sells ASTM Documents
IHS is a leading provider of online access to large document collections from ASTM. For more information and a price quote, please complete the form below.
ASTM Int'l Complete
ASTM Digital Library
ASTM Petroleum Products
ASTM Steel
ASTM Construction
ASTM Insulating Materials
ASTM Metals
ASTM Paints
ASTM Plastics
ASTM General Test Methods
First Name:

Last Name:

Email address:
ASTM International Committee E55 on Manufacture of Pharmaceutical Products approved ASTM E 2537 - Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing.

The purpose of ASTM E 2537 is to address the application of continuous quality verification to those manufacturing processes that employ modern quality management systems often supplemented with modern process analytical chemistry systems and controls, according to ASTM International.

The standard is under the jurisdiction of Subcommittee E55.03 on General Pharmaceutical Standards.

"Continuous quality verification is an alternative process validation approach whereby the desired quality attributes are ensured through continuous assessment during manufacture," said Graham Wrigley, E55 member and senior manager, PGM Global Quality Operations Center, Pfizer Inc.

"The adoption of this quality approach will move us from the documentation of a discreet process validation exercise to a science-based systematic approach. With the knowledge obtained during the product life cycle, a number of benefits may be afforded, for example, real-time release and continuous quality improvement."

Pharmaceutical manufacturers that have batch or continuous processes that employ analyzers and controllers that monitor, measure, analyze and control the process performance will be the primary users of the standard.

Parties involved in pharmaceutical and biopharmaceutical manufacturing, research and development and process analytical technologies are invited to participate in future work on ASTM E 2537.

Source: ASTM International.

ENGINEERING STANDARDS & REGULATIONS NEWS
November 5, 2009
ISO, ILAC, IAF Streamline Quality Mgmt. Requirements for Medical Labs
In a joint communiqué by the International Organization for Standardization (ISO), the International Laboratory Accreditation Cooperation (ILAC) ... more
October 30, 2009
ASTM D7558 Addresses Medical Glove Allergens
ASTM International issued a standard that allows rubber glove manufacturers to monitor the level of residual chemicals in their end products ... more
October 30, 2009
ANSI Begins Accreditation Under Toy Safety Certification Program
The American National Standards Institute (ANSI) accredited five certification bodies under the new Toy Industry Association (TIA) Toy Safety ... more
October 23, 2009
EU-China Standards Information Platform Launched
The European Committee for Standardization (CEN) announced the official launch of the new EU-China Standards Information Platform, a project ... more
October 16, 2009
DIN Announces Launch of Germany-China Standards Information Portal
The German Institute for Standardization (Deutsches Institut für Normung e.V., or DIN) announced the launch of the new Germany-China Standards ... more
Show All..