FDA Looks to Modernize Sterile Injectable Inspections

With an eye toward averting drug shortages and sterility question marks, the US Food and Drug Administration (FDA) is modernizing its inspections program with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs.

The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more efficient analyses. The protocols also include additional questions related to quality culture in facilities.

The primary focus of the new protocols is to ensure a more streamlined and consistent coverage and reporting of FDA’s inspectional activities.

The first phase of NIPP developed a protocol that could be used during aseptic processing surveillance and pre-approval inspections. In explaining its decision to begin with facilities using aseptic processing to manufacture sterile drug products, FDA noted the significant impacts on patient safety if the quality of drugs that are intended for sterile injection are compromised. In addition, the agency noted the challenges in recent years related to quality issues that have led to shortages of sterile, parenteral drugs.

For instance, in February 2017, FDA sent a warning letter to Pfizer’s Hospira sterile injectable site in Kansas, finding that the company’s investigations into complaints of visible particulates were inadequate. And according to the Government Accountability Office, since 2012, the number of ongoing shortages (shortages that began in years prior) has remained high, with over 250 ongoing shortages each year from 2012 through 2015 and in 2015, 68% of shortages were ongoing shortages, most of which were for generic sterile injectable drugs.

With better and more consistent oversight of these manufacturing facilities, FDA hopes to be able to spot problems earlier and implement mitigation steps that can avert shortages.

“These aseptic processing drug inspection protocols for sterile drugs are the first of what we plan to be a series of valuable new inspection protocols covering all dosage forms,” FDA Commissioner Scott Gottlieb said. “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.”

FDA notes that each new protocol underwent extensive revision and refinement, with direct feedback from FDA investigators, compliance officers and reviewers who participated in the pilots.