Navigation Links
ISPE Announces Recruitment Milestone Achieved for Its Quality Metrics Pilot Program
Date:8/8/2014

TAMPA, Fla., Aug. 8, 2014 /PRNewswire-USNewswire/ -- ISPE announced today that its Quality Metrics Pilot Program has achieved a major milestone with confirmation of 12 companies and 32 sites participating in the Program, even as recruitment continues. In line with an objective of the Pilot Program, the companies represent generic, innovator, over-the-counter, contract manufacturing and analytical businesses with a good spread of technologies – solid dosage, sterile, drug substance, small and large molecule.

"Gaining early commitment to the ISPE Metrics Initiative by such a broad group of industry companies is a profound achievement by the ISPE Quality Metrics Team and its extended work streams," said Nancy Berg, ISPE President and CEO.  "The companies are clearly leaders and pioneers. Through their participation, this program will make a major contribution to industry by recommending innovative quality and regulatory practices."

At a face-to-face meeting of the Quality Metrics team during the week of July 14th, arrangements were made to establish multiple forums that will enable participating companies to influence the outcome of the Pilot Program. There are also opportunities for participants to develop insights into the quality performance of their sites.

Participating companies will provide up to 12 months of historic and a limited amount (3 months) of current data as Wave 1 of the Program. A Wave 2 is being planned which will:

  • Expand the number of participants
  • Assess a potentially adjusted metric set based on learning from Wave 1 and status of any regulatory announcements
  • Include input from sub teams working on Leading Quality Indicators/Quality Culture and Process Capability
  • Be based more on current data collection and analysis
  • Consider cooperating with other groups and associations

The objective of the Pilot Program is to provide experiential input on the development and use of quality metrics for the benefit of both industry and regulators.

The level of interest from companies is high. We anticipate more companies joining Wave 1 and we are actively recruiting for Wave 2.

More information relating to the ISPE Quality Metrics Program can be found in previous announcements and in the Q&A given on the web site.

If you would like your company to participate in the pilot, please contact PQLI@ispe.org or McKinsey & Company at 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
Associate Director, Marketing Communications, ISPE
Tel: +1-813-960-2105, ext. 309
Email: rsmith@ispe.org 

Logo - http://photos.prnewswire.com/prnh/20120912/DC73253LOGO


'/>"/>
SOURCE ISPE
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... Feb. 5, 2016  Redwood Scientific Technologies, Inc. announced ... designed to help women balance their hormones. This product ... Jason Cardiff , President and CEO. ... to help the millions of women across the country ... of imbalanced hormones. Our research and development team is ...
(Date:2/5/2016)... , Feb. 5, 2016  Patients in Alabama ... focused ultrasound (HIFU) therapy no longer have to travel out ... its partnership with Urology Centers of Alabama to ... FDA-cleared procedure for qualifying patients. Alabama ... in the treatment of prostate cancer using many different modalities. ...
(Date:2/5/2016)... 5, 2016  Venice,s newest laser clinic, ... of its kind in the area and specializes ... laser treatment. The physician-owned and operated laser clinic ... by storm with its revitalizing skin care approach, ... Astanza Trinity technology. http://photos.prnewswire.com/prnh/20160204/329957 ...
Breaking Medicine Technology:
(Date:2/8/2016)... Houma, LA (PRWEB) , ... February 08, 2016 ... ... Louisiana from offices in Houma, LA, celebrates the beginning of a new charity ... raised to assist Court Appointed Special Advocates (CASA). In the belief that children ...
(Date:2/8/2016)... ... , ... If you are feeling that your clothes are a tad snug, ... the Center for Disease Control and Prevention (CDC), 34.9% of U.S. adult women are ... cancer, some of the leading causes of preventable death. February is heart health ...
(Date:2/8/2016)... ... February 08, 2016 , ... Local ... the greater Venice, FL area, has initiated a fundraiser for a two year ... just four days after Christmas. To support this beautiful child who is facing ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... ... that co-occur frequently. While a significant number of women and men with eating ... the trauma itself, that best predicts the development of an eating disorder. ...
(Date:2/8/2016)... ... February 08, 2016 , ... The ... important news! AHCC and the Home Health and Hospice ICD-10 Transition Workgroup are ... official ICD coding guidance and clarifications, to address concerns over the use of ...
Breaking Medicine News(10 mins):