FDA’s Center for Drug Evaluation and Research (CDER), in conjunction with the agency’s field organization, has developed and is piloting a new inspection protocol that will impact the scope of what investigators are looking for and how they are assessing and reporting what they find.
The “New Inspection Protocol Project” (NIPP) expands the investigator’s focus beyond uncovering specific cGMP violations to assessing the overall state of a manufacturer’s quality systems and operations – the strengths as well as the weaknesses.
The goal is an inspection report that: • is better organized, more transparent and searchable, and less subjective • allows for easier evaluation, measuring, tracking, and comparisons • can be produced in a semi-automated fashion • focuses on more than violations, and • is more useful in driving manufacturing improvements.
FDA views its protocol effort as a potential foundation for a more internationally harmonized inspection approach and improved inter-agency communication in line with the ICH Q8-12 guideline series.
At a breakfast session at the PDA/FDA joint regulatory conference in September in Washington, DC, CDER Office of Pharmaceutical Quality (OPQ) Office of Process and Facilities (OPF) Acting Deputy Director David Doleski provided the background, current status and future plans for NIPP and how the project fits into the larger quality regulatory paradigm shift the agency and OPQ is working to accomplish.