FDA Weighs New Inspection Scoring System
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices.
The system, which hasn’t been finalized, would offer drugmakers six scores: critical failure, major failure, minor failure, acceptable, exceeds and superior. Drugmakers would receive a score for each aspect of an inspection, including whether a facility meets GMPs, has an adequate quality system and quality culture.
The proposed system is part of an inspections protocol project that is intended to revamp the inspection process so CDER gets a better idea of a facility’s state of quality.
The scores would be given in addition to the traditional overall classifications: no action indicated, voluntary action indicated and official action indicated, Neil Stiber, CDER senior operations research analyst, said after a session at the Parenteral Drug Association’s quality metrics conference.
The scores are intended to provide more information to drugmakers than the broad classifications, and won’t interfere with the process for levying enforcement actions such as Form 483s, Stiber said. The scores also wouldn’t directly translate into an inspection classification such as NAI, OAI or VAI.
Inspection classifications depend on many factors, including prior issues, drug availability and how well the facility responded to problems previously, he said. Those issues will still help determine the inspectional outcome, such as NAI, OAI and VAI.
A goal of the scoring system would be to recognize manufacturers that go beyond meeting agency regulations and GMPs. High-quality facilities could act as role models for the rest of industry, and encourage the whole industry to improve quality, Stiber said.
The scoring system would also provide more specific feedback on inspection results than the broad, overall classifications, he added.
Any score also would be in addition to the upcoming ranking that a facility will receive based on a series of quality metrics. The rankings will be used to compare manufacturers to the rest of industry and determine inspection frequency.
Stiber declined to comment on when CDER will make a decision on the scoring system.
Agency officials have offered details on other parts of the inspection protocol project. Next year, for example, CDER will conduct an internal pilot wherein investigators will be trained to examine a facility’s quality culture for the first time. Such investigators would start looking for quality culture indicators during inspections within the next few years.
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