ISPE Announces Recruitment Milestone Achieved for Its Quality Metrics Pilot Program
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.
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.
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