By Daniel R. Matlis
According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every 2 years.
There is just one problem, the number or registered human drug establishments has increased in the last 25 years while the number of FDA human drug inspections has decreased over the same period. To address this issue, the FDA has implemented the “Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites”. This model, commonly known as the Site Selection Model, utilizes a risk-based inspection approach for prioritizing drug manufacturing establishments for routine cGMP inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. Currently there are 3 empirical factors used to calculate a site’s selection score.
- Product Risk: Factors such as sterility, medical gas, and the determination of prescription (Rx) versus over the counter (OTC) currently in the model are crude surrogates to distinguish between products with higher and lower potential for public health consequence should there be a drug defect.
- Process Risk: Some processes are more complex and more susceptible to problems than other processes. The key issues in the implementation of the risk-ranking model involves questions concerning the relevant inherent process risk factors, the relevant process control and risk mitigation factors, and how to weigh/rank them
- Facility Risk: Currently, the facility component of the risk ranking model includes 4 factors:
- History of violation (e.g., CGMP deficiencies have higher weights)
- History of inspection (e.g., no prior inspection, newly registered/licensed or no CGMP inspection in the past 2 years have higher weights than those with recent CGMP inspection)
- Estimated volume of production output (surrogate for exposure, e.g., higher volume and production output, higher weights)
- Type of establishment (e.g., manufacturer, repacker, contract lab)
According to Joseph Famulare, acting Director of CDER’s office of compliance, in addition to these three empirical factors, “expert elicitation with emphasis on current FDA priorities is used to determine site selection”. “For example, last year trans-dermal patches were a priority at the agency” said Famulare, so the number of inspection in that area increased.
Famulare said “just under 50% of the cGMP inspections last year were based on the Site Selection Model, with the remainder done at the districts discretion.”
Next year, a new category will be factored in the empirical portion of the calculation. Recall data has already been entered in the database and will be used for Site Selection Model.
You heard about your credit score, it’s time to keep and eye on your Site Selection Score.