ISPE continues to lead the charge in bringing the industry and regulators together to discuss quality metrics.  Recently, ISPE submitted comments to the FDA on the draft guidance, Request for Quality Metrics, based on the data-driven findings from our Quality Metrics Pilot Program Wave 1 and 2.

  • Wave 1 centered on testing the feasibility of collecting and reporting a standardized set of quality metrics.  The FDA added ISPE’s Quality Metrics Initiative: Wave 1 Report to their quality metrics administrative record.
  • Wave 2 provided participants experience in preparing the logistics and efforts associated with gathering of product-based data, including the FDA proposed quality metrics set.

ISPE’s key messages were based upon the findings of our Quality Metrics Pilot Program, and emphasized that ISPE:

  • Supports FDA’s effort to implement a Quality Metrics Program
  • Stands by the need for the program to start with a small, targeted approach
  • Recommends a phased introduction that will maximize learning, minimize burden on both the industry and FDA and enhance the chances of a successful implementation
  • Advocates starting with three of the proposed metrics
  • Is concerned the burden to the industry is underestimated, based on the industry’s experience, both in terms of upfront investment and ongoing cost
  • Requests greater transparency in the manner in which data will be assessed, and outcome and conclusions determined and communicated

In addition to providing individual feedback, ISPE was a highly active contributor to a Cross Industry Quality Metrics Collaboration Group.  This group represents a broad informal group across the pharmaceutical industry including:

  • Active Pharmaceutical Ingredients Committee (APIC)
  • Biotechnology Industry Organization (BIO)
  • Bulk Pharmaceuticals Task Force (BPTF)
  • Consumer Healthcare Products Association (CHPA)
  • Generic Pharmaceutical Association (GPhA)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Pharma & BioPharma Outsourcing Association (PBOA)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)

The Collaboration Group believes Quality Metrics should be a means for incentivizing and improving quality, not a punitive measure.  The group requested the FDA adopt a phased-in approach as well.

A phased-in approach will allow the industry an opportunity to understand and interpret the definitions and parameters of the program in a sandbox type of environment to ensure all aspects are covered before going “live”.  Furthermore, implementation of FDA’s proposed Quality Metrics program may require considerable support internally and externally.  Manufacturers may be required to make changes to the types of data collected, reporting structures, electronic systems, review processes, confidentiality and quality agreements – which impact the business practices of the entire supply chain.

In addition to the phased-in approach, the Collaboration Group provided the following recommendations pertaining to the proposed Quality Metrics program:

  • Reporting period to not commence until at least six months after the FDA issues its final guidance
  • Reporting should be done annually with specific submission dates determined by each firm to balance workload and align with existing quality system procedures
  • Trending should be incorporated into the analysis model
  • FDA to provide time to make adjustments and provide clear guidance about who is accountable for reporting which metrics
  • FDA clarify if and under what circumstances API manufacturers should report their own data and how that date should be reported

ISPE appreciated the opportunity to provide input on the proposed Quality Metrics program to the FDA and the Collaboration Group and aspires to maintain the open dialogue with the FDA.  ISPE will continue to be ready to assist in the Quality Metrics program through continued technical and regulatory input to the FDA through the Pilot Program Wave 2, education conferences and forums.

Review documents submitted to FDA by ISPE and The Cross Industry Quality Metrics Collaboration Group.