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From Health Law Daily, September 6, 2018

Risk-based prioritization supports drug safety, efficacy and promotes resource efficiency

By Patricia K. Ruiz, J.D.

The FDA’s Center for Drug Evaluation and Research released documentation explaining its risk-based site-selection model (SSM), which is used to prioritize drug manufacturing sites for routine quality-related surveillance inspections. The SSM considers the risks related to drug quality that may arise from a violation of current good manufacturing practice (CGMP) requirements to promote parity in inspectional coverage and effective and efficient use of FDA resources (Understanding CDER’s Risk-Based Site Selection Model, September 5, 2018).

Adoption of risk-based approach. In fiscal year (FY) 2005, following the initiative Pharmaceutical Quality for the 21st Century – A Risk-Based Approach, the FDA implemented a risk-based approach to prioritizing human drug manufacturing sites for routine CGMP surveillance inspection. This replaced the previous approach, which was primarily based on the biennial inspection frequency for domestic sites under the Food, Drug, and Cosmetic Act (FDC Act). The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 amended the FDC Act and replaced the fixed minimum inspection interval for domestic establishments with the requirement that the FDA inspect foreign and domestic drug establishments on a risk-based schedule to promote parity in inspectional coverage and effective and efficient use of FDA resources.

Prioritization of site surveillance. The office of Surveillance (OS) within the Office of Pharmaceutical Quality produces the Site Surveillance Inspection List (SSIL), which prioritizes sites for surveillance inspections using the SSM. In determining inspection priority, the SSM considers the risk related to drug quality that may arise from violation of CGMP requirements and related regulations. The SSM ranks the subject sites so that higher risk sites are assigned to the Office of Regulatory Affairs (ORA) for surveillance inspection. The risks considered include:

  • site type;
  • time since last surveillance inspection;
  • FDA compliance history;
  • foreign regulatory authority inspection history;
  • patient exposure;
  • hazard signals; and
  • inherent product risk.

Cooperation and harmonization globally. The FDA stated in a press release that in addition to these efforts, cooperation with foreign regulators is critical to ensuring that drug supply produced outside of the U.S. meets the FDA’s safety and efficacy standards. To that end, the FDA participates in the Pharmaceutical Inspection Co-Operation Scheme, which focuses on harmonizing the way inspections are conducted. It also participates in the International Council for Harmonisation, which was established to facilitate international collaboration to standardize and elevate drug development practices and quality standards worldwide. The FDA expressed its commitment to fostering advanced manufacturing practices in a way that leads to more innovative, consistent, and dependable manufacturing of drug and biological products.

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