FDA Modernizing Inspections with New Protocols
After several years of planning, FDA says it implementing its “New Inspection Protocol Project (NIPP)” to modernize inspections with a “new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products. FDA commissioner Scott Gottlieb says the “new tool is being applied to our inspectional work related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past. The primary focus of this new tool is to ensure a more streamlined and consistent coverage and reporting of our inspectional activities.”
NIPP was unveiled in 2015 as an initiative under CDER’s new Office of Pharmaceutical Quality (see story). At the time, Center officials touted it as a better approach to monitor quality. “NIPP is expected to provide a more quality-focused, semi-quantitative approach with streamlined and structured inspection reports,” they said. “The NIPP protocols utilize expert investigator questions and assessment approaches. NIPP is expected to increase the quality focus of investigator assessments, so that facilities and behaviors found to exceed basic compliance can be recognized as such. Following successful piloting, NIPP-developed protocols will be incorporated into new mobile technology to capture investigator findings and assessments and better support investigators while traveling and during facility inspections.”
According to Gottlieb, the protocols also include additional questions related to quality culture observed in facilities. “The first phase of NIPP was aimed at developing a protocol that could be used during aseptic processing surveillance and pre-approval inspections,” he writes. “Facilities using this processing technique to manufacture sterile drug products were a logical starting place because of the significant impacts on patient safety if the quality of drugs that are intended for sterile injection are compromised; and because of the challenges that we’ve had in recent years related to quality issues that have – at times – led to shortages of sterile, parenteral drugs. With better and more consistent oversight of these manufacturing facilities, we hope to be able to spot problems earlier and implement mitigation steps that can avert dangerous drug shortages.”
The new protocols won’t change investigators’ roles, Gottlieb promises. The protocols have been piloted and refined based on “feedback received from our investigators, compliance officers and reviewers who participated in the pilots,” he says. “The result is protocols that promote consistent and comprehensive coverage of critical areas of sterile drug manufacturing and provide structured, data-rich reports that can be used to quickly assess the state of quality in drug manufacturing facilities while maintaining flexibility for investigators to adapt inspections based on constraints such as time or the seriousness of violations. The structured protocol also makes it easier to analyze data to find anomalies and inform decisions that can reduce risks to patients.
“These aseptic processing drug inspection protocols for sterile drugs,” Gottlieb continues, “are the first of what we plan to be a series of valuable new inspection protocols covering all dosage forms. As we integrate learnings from these pilots in our field activities, our goal is to have them ready for full implementation within the next two years.”