FDA New Inspection Protocol Project:  New Improved Way for GMP Audit
​​[Posted on: Thursday, October 13, 2016]

Last year FDA’s newly formed Office of Pharmaceutical Quality (OPQ) announced that it would update its GMP inspections process to add risk-based factors whereby sites with higher risk will be given more attention and sites that exceed basic compliance will be rewarded. The program which was named New Inspection Protocol Project (NIPP) would change the regulatory paradigm of GMP inspections by standardizing data gathering during inspections, using a question-answer based reports with a semi-quantitative scoring to allow for comparisons within and between sites, and a common inspection report structure. This seems like in many ways, an effort to harmonize FDA’s GMP inspections with best practices followed by other regulators, particularly PIC/S. Additionally, FDA announced that it would create a new recognition and reward system for GMP sites found to exhibit good compliance behavior; however, it is not clear what that would look like. FDA does not have any similar system to reward companies for “better” compliance. Does, it mean that FDA will start giving some sort of certification of compliance or reduce the frequency of GMP audit for “better” sites and a penalty system for sites that are “worse”? In inspections by other regulatory bodies and the industry it is fairly common to score compliance status of GMP sites in a semi-quantitative manner to compare sites. So, it should not be difficult or onerous for FDA to implement a similar system, however, it would require additional thought from FDA. FDA announced that NIPP will be initially launched as a pilot program to collect feedback and experience from the inspectors before it is formally implemented. In the year since its initial announcement, the NIPP program has not been initiated yet but is expected to start next year. The program was one of the 5 areas of priority for OPQ. As FDA inspections become more transparent and semi-quantitative, it is bound to be mutually beneficial to both FDA and the industry.