In an effort to address the major underlying causes of drug and biological product shortages, the U.S. Food and Drug Administration (FDA) is seeking new ideas to encourage high-quality manufacturing and to facilitate expansion of manufacturing capacity.
ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since it was brought to the forefront of industry thinking in the Food and Drug Administration Safety and Innovation Act (FDASIA).
16 June 2014: Quality Metrics Pilot Launched
The program to demonstrate the feasibility and value of standard Quality Metrics is officially underway and now open to any drug manufacturing company that is registered with FDA.
12 March 2014: ISPE Announces Plan to Conduct Quality Metrics Pilot Program
ISPE will conduct the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the FDA. The pilot will refine the proposed set of metrics and definitions, data submission process, and evaluation.
20 December 2013: ISPE Proposals for FDA Quality Metrics Program – Whitepaper
At the invitation of FDA, the ISPE Quality Metrics working group developed a whitepaper on potential measures of product quality, site operations quality and site systems performance. The recommendations contained in the paper stem from robust industry - FDA discussions facilitated by ISPE’s Quality Metrics working group.
6 December 2013: Status Report Released
The ISPE Quality Metrics working group released a status report detailing an initial list of quality metrics considered acceptable to industry as a starting point. These metrics would be reportable to FDA to support a risk-based inspection program as called for in sections 704 to 706 of FDASIA, and should assist industry in moving towards the 'desired state.'
November 2013: ISPE and FDA Present Initial Recommendations
Robust industry/regulator conversations continued as the ISPE Quality Metrics Task Teams presented their initial recommendations for comment and input at two capacity-attendance sessions at the ISPE Annual Meeting in Washington, D.C.
June 2013: ISPE Leads Industry/FDA Workshop
The industry’s first public industry-regulator dialog was held at the 2nd Annual ISPE-FDA CGMP Conference, Baltimore, Maryland, USA. Task Teams were formed to continue working in the areas of Out of Specification/Laboratory Failure Investigation Rates, Batch Failure Rates, and Leading Metrics/New Ideas.
Please send any feedback to PQLI@ispe.org.