ThomasNet News Logo
Sign Up | Log In | ThomasNet Home | Promote Your Business

ISPE announces launch of Metrics Pilot Program.

Print | 
Email |  Comment   Share  
June 24, 2014 - ISPE has announced official launch of its Metrics Pilot Program, which is headed by ISPE’s PQLI Quality Metrics Team, and is now open to any drug manufacturing company that is registered with FDA. Primary objectives are to test harmonization of definitions for industry consensus metrics that represent both leading and lagging indicators, and to test feasibility of data collection across companies who are at different maturity levels with their own internal metrics programs.

ISPE Announces Quality Metrics Pilot Launch


ISPE
600 N. Westshore Blvd., Suite 900
Tampa, FL, 33609
USA



Press release date: June 16, 2014

—Program to demonstrate the feasibility and value of standard Quality Metrics is officially underway—

(TAMPA, FLORIDA, USA) – At the 3rd annual ISPE-FDA CGMP Conference, ISPE announced the official launch of its Metrics Pilot Program. The launch of the pilot, headed by ISPE’s PQLI Quality Metrics Team, is a major milestone in the overall project from ISPE. The pilot is now open to any drug manufacturing company that is registered with FDA. The intention is to encourage participation from a broad spectrum of technologies and types of companies within the pharmaceutical industry.

“ISPE is committed is to helping industry identify and define the metrics that are truly indicative of quality,” said Nancy Berg, ISPE’s President and CEO. “Attention to the ‘right’ metrics can help promote positive behaviors and instill in companies a corporate culture of responsibility for quality. ISPE’s Pilot also will explore the opportunities and challenges associated with how metrics are collected and interpreted, as well as consider possible next steps in metrics implementation.”

The ISPE Quality Metrics team was charged with identifying and defining metrics that reflect quality and determining metrics to be applied to sites versus those applied to products. The metrics selected for the pilot were specifically chosen to enable assessment of site, product and quality system performance.

There are multiple benefits that can be achieved from this pilot. Some important primary objectives for the pilot’s initial phase are to:

Test harmonization of definitions for industry consensus metrics that represent both leading and lagging indicators
Test feasibility of data collection across companies who are at different maturity levels with their own internal metrics programs

Participants also will gain the added benefits of:

Blinded comparison among their technology platform peers
A head start on establishing internal procedures for metric collection along with a set of metric definitions
Insight into implications for metric implementation

The well-attended CGMP Conference also highlighted a broader view of metrics implementation with plenary presentations from US FDA, Pfizer, and Peking University.

McKinsey & Company is partnering with ISPE on the Pilot and will confidentially manage data collection and analysis. Each participant will establish a confidentiality contract with McKinsey.

For additional information about ISPE’s Quality Metrics Pilot and to become a pilot participant, please contact ISPE_pilot@mckinsey.com.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for more information.

For more information contact:
Renee Smith
Sr. Manager, Marketing Communications, ISPE
Tel: +1-813-960-2105, ext. 309
Email: rsmith@ispe.org
www.ISPE.org
Print | 
Email |  Comment   Share  
Contacts: View detailed contact information.


 

Post a comment about this story

Name:
E-mail:
(your e-mail address will not be posted)
Comment title:
Comment:
To submit comment, enter the security code shown below and press 'Post Comment'.
 



 See related product stories
More .....
 See more product news in:
Services
 More New Product News from this company:
Educational Sessions/Workshops highlight ISPE conference.
More ....
| Featured Manufacturing Jobs
 Other News from this company:
ISPE Announces Development of New Drug Shortages Prevention Plan for the Pharmaceutical Industry
Southeast's Largest Annual Gathering of Life Science Professionals
Find Smart Solutions for Lifecycle Innovation at Pharma EXPO Debut
FDA's Thomas Arista and Rick Friedman Confirmed as Keynote Speakers at 23rd Annual ISPE Aseptic Conference
More ....
 Tools for you
Watch Company 
View Company Profile
Company web site
More news from this company
E-mail this story to a friend
Save Story
Search for suppliers of
Trade Associations


Home  |  My ThomasNet News®  |  Industry Market Trends®  |  Submit Release  |  Advertise  |  Contact News  |  About Us
Brought to you by Thomasnet.com        Browse ThomasNet Directory

Copyright © 2014 Thomas Publishing Company. All Rights Reserved.
Terms of Use - Privacy Policy



Error close

Please enter a valid email address