QMISPE, along with the support of McKinsey & Company, is finalizing a meaningful program that will help standardize the use of metrics across industry while supporting the request of the FDA for a risk-based inspection program. Participants in this pilot will be on the leading-edge of bringing innovation to the quality performance assessment of manufacturing sites. It will also allow participants the opportunity to begin setting up internal processes and ensure the feasibility of data collection.  Another exciting opportunity is the ability to benchmark your site’s performance with other participants.

The ISPE PQLI® Quality Metrics team would like to announce the following information that represents significant work and decision-making to date:

  • The team members developing this pilot program have been finalized and represent a diverse segment of pharmaceutical industry, technical experts and academia.
  • An initial set of industry consensus and leading quality metrics has been selected and defined to provide an evaluation of a manufacturing site quality performance, regardless of product, technology or size.
  • The pilot will also collect information on Process Capability and Quality Culture.
  • A process for data collection has been created and guidance on the metrics and process will be provided to each participant.
  • The pilot is open to individual manufacturing sites that are registered with the US FDA and we are seeking companies that represent:
    • US and Foreign sites
    • Branded, Generic and OTC
    • Manufacturers of Drug Substances / APIs, Finished Products and Contract Manufacturers from different technologies, such as, but not limited to:
      • Biological / Large Molecules
      • Chemical / Small Molecules
      • Oral Solid Dosages
      • Steriles
    • There is no requirement or limitation with regard to a site’s size, production / sales volume or number of employees.
    • A company may register more than one site.
  • A fee will be charged to registrants to support the costs of data collection and analysis
  • Strict confidentiality of data will be maintained for every participant

The goal of this pilot program is just that, a pilot. We want to understand how the harmonization of metric definitions apply to various sites, how easy it is to collect and submit quality metrics data, what does the data tell us, where are there correlations between data sets and what doesn’t work. This work is imperative to make a final recommendation.

More information on this exciting opportunity will be provided at the ISPE – US FDA CGMP Conference 2 – 4 June 2014 at the Hilton Baltimore. A formal presentation on the project will be presented Monday, 2 June at 9:55 EDT and an informal Q&A session will be held Tuesday, 3 June at 17:00 EDT which will allow conference participants to interact and communicate with the entire Metrics Team.