The International Society for Pharmaceutical Engineering (ISPE) is searching for common ground between the FDA and industry on quality metrics, which the agency believes can improve drug quality and drugmakers contend will only cause confusion.
The association announced the quality metrics project in the Sept.-Oct. issue of its journal Pharmaceutical Engineering. The goal is to develop a white paper acceptable to industry and regulators that defines objective metrics for use in a risk-based inspection program.
Prompted by new legislative mandates for more risk-based inspections, the FDA recently asked drugmakers to share their methods for measuring manufacturing quality, and asked whether such “metrics” should be used to guide patients and prescribers in their product choices. Some commenters said such metrics are “internal” tools that, if applied globally to guide consumer choices, would upend drug markets.
The project started during a June ISPE conference where attendees at a workshop voiced lingering questions about the challenges surrounding quality metrics, including:
Should they be measured by site, product or company?
Does the metric truly reflect quality and/or compliance? and
Would their wider use lead to unacceptable behavior by industry or regulators?
After reviewing the feedback, ISPE decided to focus on quality metric topic areas that include out-of-specification failure investigation rates and batch failure rates.The idea is for industry leaders to first test any metric suggestions developed by the ISPE and then allow the agency to discuss them. An update on the project will be given at the association’s annual meeting in November in Washington, D.C. The association plans to publish the white paper sometime after the meeting.
The group said it understands the challenges it faces reaching consensus between industry and the FDA. “Nonetheless, there is enthusiasm to move forward and explore what practical and acceptable quality metrics could be developed which are useful to industry and regulators,” the association says.
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