Guide To The FDA New Inspection Protocol Project [NIPP]
The NIPP will revolutionize the way the FDA manages pharmaceutical inspections. This article will describe the framework of this initiative, and what it is intended to achieve.
In 2015, the FDA announced its five Strategic Priorities for 2015 through 2018. From the following priorities, the New Inspection Protocol Project (NIPP) was born:
- Regulatory Science
- Globalization
- Safety & Quality
- Smart Regulation
- Stewardship
Among the Strategic Priorities, NIPP focuses on Regulatory Science. Aligning with these priorities, the New Inspection Protocol Project falls under CDER’s Office of Pharmaceutical Quality (OPQ), whose motto is “One Quality Voice.” This motto means that OPQ’s goal is to standardize global regulation of all pharmaceutical products to the same specifications and performance criteria. NIPP, as part of OPQ, focuses on the content of inspection reports with the aim of creating a system for inspection reports that are better-organized, searchable, less subjective, and semi-automated.
The project will take place over two years to drive improvements to inspections and reports. NIPP seeks to expand the scope of regulatory inspection from merely identifying GMP violations, to assessing the scope of a company’s quality system and operations, both good and bad. The FDA anticipates these changes will drive pharmaceutical quality improvements.
The key difference in NIPP from current practice is that NIPP will use informatics, internal analysis, and other computerized tools to prepare for and guide inspections. Leveraging the power of big data and predictive analytics, algorithms developed through NIPP will reveal product quality anomalies to help inspectors focus on high-risk operations within each pharmaceutical production facility. Inspections that concentrate on high-risk, inconsistent processes and products will save inspection time and expedite desired pharmaceutical quality improvements.
Organizationally, the NIPP is divided into three subgroups: The pre-approval Inspection Protocol(s) subgroup, the Surveillance Inspection Protocol(s) Subgroup, and the For Cause Inspection Protocol(s) Subgroup. These groups will mine regulatory data to improve the FDA’s understanding of consistent behaviors that drive an understanding of product quality risk. These groups will further collaborate to create a consistent scheme for identifying and grading regulatory findings.
The FDA uses informatics as the cornerstone of NIPP. A database will evaluate the history of a given pharmaceutical manufacturing site for the following eight facility risk factors:
- Process
- Research
- Analytical Methods
- Sterility/Microbiology
- Inspections
- APIs and Excipients
- Chemistry Manufacturing and Controls (CMC), and
- Policy/Enforcement Actions
An algorithm will integrate the findings from the historical data, and integrate them with product and facility risk factors to calculate a site ranking. Such metrics-based regulatory science can identify higher-risk pharmaceutical manufacturing sites for inspection. These data can also help to reduce inspection man-hours while improving overall inspection value.
The FDA wants this model to become a Best Practice for inspections, and hopes for world-class recognition. If all goes well for the FDA, the ICH (International Council on Harmonisation) will benchmark NIPP as the ideal program for inspecting pharmaceutical manufacturing sites.