FDA Outlines Plans To Modernize Inspections for Sterile Injectable DrugsBy
The US Food and Drug Administration (FDA) plans to take new steps to modernize its inspections program with a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products.
The FDA is moving forward with a New Inspection Protocol Project (NIPP), which uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight of facilities and faster and more efficient analysis of findings. The protocols also include additional questions related to quality culture observed in facilities. The new tool is being applied to the FDA’s inspectional work related to sterile injectable drugs, which have been the subject of sterility problems and shortages in the past.
The first phase of NIPP was aimed at developing a protocol that could be used during aseptic processing surveillance and pre-approval inspections. “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,” FDA Commissioner Scott Gottlieb said in a November 9, 2018 agency statement. “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 FDA says the new protocols won’t change the role of the investigator, which continues to be collecting, evaluating, and documenting objective facts about the state of pharmaceutical quality of drug manufacturers. The protocols provide a more structured and informative tool for completing inspections.
The FDA notes that it conducted multiple pilots of the NIPP protocols to help ensure that they would be consistent with current program objectives and integrate into the way investigators conduct inspections. Each new protocol version underwent extensive revision and refinement, according to information from the FDA.
“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,” Gottlieb said in his statement. “The structured protocol also makes it easier to analyze data to find anomalies and inform decisions that can reduce risks to patients.”
The agency says these aseptic processing drug inspection protocols for sterile drugs are the first in a plan for a series of 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,” Gottlieb said in the statement.