Risk-based method for prioritizing cGMP inspections of pharmaceutical manufacturing sites—a pilot risk ranking model
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) explains the pilot risk ranking model, a risk-based method for prioritizing current good manufacturing practices (cGMPs) inspections of pharmaceutical manufacturing sites. The paper discusses categories of risk rankings, which should be logically consistent, administratively compatible, equitable and compatible with cognitive constraints and biases. It also discusses the general process for risk ranking, estimation and and filtering, and the four facility components of the ranking, including history of violation and inspection, estimated volume of production output and type of establishment.
| Published: | 2004 |
| Format: | |
| Length: | 18 pages |
| Type: | White paper |
| Language: | English |
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