FDA Implements NIPP to Sterile Injectables GMP Inspections: Other to Follow
​[Thursday, December 6, 2018]

Last week FDA announced that is has implemented a standardized, electronic semi-automated inspection protocol to GMP sites for sterile injectables with plans to expand the program to all GMP inspections or audits. The new GMP inspections protocol created under the New Inspections Protocol Project (NIPP) is a culmination of several years of planning, testing and optimization to help FDA inspectors focus their attention to critical areas of the site being inspected, while expanding the amount of data reviewed. Although the announcement is scant on the details of the new protocol, some key elements are obvious. First, the inspection process itself has not changed; the inspectors will still visit the GMP sites to collect, evaluate and document objective facts, but they would use standardized electronic questionnaire-based tools to capture observations and automatic generation of establishment inspection report (EIR) at the conclusion of the inspection. The EIR is an important record generated at all inspections which may or may not lead to FDA 483s. Second, the standardized inspection protocol is based off a pilot program where FDA inspectors participated to help create a consistent questionnaire and process. The first area of inspections was that for sterile injectables due to the higher complexity of these GMP sites. The end-product according to the FDA is an inspection protocol that covers all 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.” So, manufacturers should see less inspector to inspector variations. Third, this does not change the preparation needed at the manufacturers end. Manufacturers should still prepare for the FDA audits as before. One should be prepared to provide all data generated at a given site and give the FDA inspector access to all areas and documents as requested. It should not change the kind of questions asked by the inspectors, nor should it affect the logistics of the inspection. Overall, this should be good news for experienced sites who have seen an influx of new inspectors and related issues, at the same time a warning for less experienced manufacturers to assure robust quality standards. And this protocol is slated for all kinds of GMP inspections, it is a notice to all GMP sites to take notice to be ready to more detailed knowledge drive inspections.