United States: FDA Releases Policy On Risk-Based Inspections

Last Updated: September 12 2018
Article by Kathleen M. Sanzo and Jacqueline R. Berman

The policy sheds light on risk factors but does not provide inspection predictability. Manufacturers should therefore continue to ensure inspection readiness.

The US Food and Drug Administration (FDA or the Agency) announced on September 5 the release of the Center for Drug Evaluation and Research's (CDER's) Manual of Policies and Procedures (MAPP), titled Understanding CDER's Risk-Based Side Selection Model (Inspection MAPP). While FDA clarified its prioritization of routine drug manufacturer surveillance inspections, it did not provide inspection predictability or otherwise indicate whether inspectional frequency will change. Accordingly, as always, manufacturers must ensure inspection readiness and biopharmaceutical quality compliance.

Inspection MAPP

As we have previously discussed here, FDA has taken a number of steps to improve its inspection process. By example, FDA implemented the amended Pharmaceutical Good Manufacturing Practices Annex to the Mutual Recognition Agreement, under which the Agency recognizes inspections conducted by certain European authorities with the aim of reducing inspection duplication.1 FDA also reorganized the office responsible for agency field activities, such that personnel, including inspectors, are now assigned based on product rather than geographic area. Moreover, as described in Commissioner Scott Gottlieb's announcement of the Inspection MAPP, FDA has updated its Inspection Classification Database in an effort to bring greater transparency to inspection outcomes.

The Inspection MAPP is another effort to shed more light on FDA's inspection process. According to the Inspection MAPP, since fiscal year 2005, FDA has used a risk-based approach for prioritizing human drug manufacturing inspections. This approach was codified in Section 510(h) of the Federal Food, Drug, and Cosmetics Act (FFDCA) in 2012, replacing the prior statutory two-year inspection cycle. In reality, however, based upon FDA's Inspection Data Dashboard, even with the implementation of a risk-based approach, many establishments are still inspected every two to three years.

Under the Inspection MAPP, sites that commercially manufacture finished pharmaceuticals, in-process materials, and active pharmaceutical ingredients for use in humans2 will be prioritized for routine inspections based on the following factors:

  • Type of manufacturing site (e.g., manufacturer, packager, control lab, etc.)
  • Time since the last surveillance inspection
  • History of compliance
  • History of inspections conducted by recognized foreign regulatory authorities
  • Patient exposure
  • Hazard signals (field alert reports, biological product deviation reports, MedWatch reports, recalls, etc.)
  • Inherent product risk (i.e., dosage form, route of administration, sterility, API load, whether the product is a biologic drug substance or drug product, therapeutic class, whether the product is a Narrow Therapeutic Index drug, and whether the product is an emergency use drug)

Using these risk factors, FDA will develop a risk score for each establishment to prioritize inspections. Some inspections, however, fall outside of this risk-based structure, including pre-approval inspections, post-approval inspections, and for-cause inspections. By example, establishments that received a classification of "Official Action Indicated" (OAI)3 during a prior inspection, are not included in this risk-based system due to the need to re-inspect the site to resolve the OAI status. Establishments on Import Alerts are also not included in the risk-based planning system. Moreover, newly registered establishments and establishments without prior routine inspections are typically inspected within 30 days and/or as a for-cause inspection.

Key Takeaways

While the Inspection MAPP is an important step in providing transparency to FDA's drug manufacturing inspection program, it does leave open a number of questions concerning what industry should expect. As a primary matter, it is unclear whether the risk-based system will change inspection frequency. Despite FDA's official departure from its biennial inspection cycle, many drug establishments continue to see FDA inspectors at their doors every two to three years. Moreover, given that FDA has used a risk-based system since 2005, the Inspection MAPP does not elucidate whether the risk factors are a public statement of FDA's existing policy or whether they are part of a new or revised policy. Accordingly, the impact of this policy is unclear.

Further, because the Agency does not note how it weights the Inspection MAPP risk factors, manufacturers will not be able to determine the likelihood of a facility being inspected in any particular year. At most, manufacturers will be able to determine whether particular occurrences or conditions are deemed by FDA to present a risk.

Although the actual impact of the Inspection MAPP is unclear, it would be prudent for manufacturers to adjust their internal quality control scorecards to align with FDA's identified risk factors. This way, manufacturers may be able to more accurately predict whether a site is developing conditions which would be deemed to present a higher risk by FDA. Such a step would assist in directing resources to higher-risk operations and ensuring inspection readiness.

Footnotes

1 As of June 1, 2018, FDA has recognized inspections conducted by 14 European inspectional authorities (the United Kingdom, Sweden, Spain, Malta, Italy, France, Croatia, Austria, Romania, Czech Republic, Hungary, Greece, Lithuania, and Ireland).

2 Human drug compounding outsourcing sites, medical gas sites, inactive ingredient sites, and sites that manufacture drugs for clinical trials do not fall within the Inspection MAPP.

3 An OAI inspection classification means that regulatory and/or administrative actions will be recommended by the Agency as a result of inspection observations. FDA, Inspections Database Frequently Asked Questions (last visited Sep. 6, 2018).

This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.

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