FDA Provides Update on Risk-Based Drug Inspections

FDA Provides Update on Risk-Based Drug Inspections

September 15th, 2018 // 8:56 pm @

FDA announced in early September 2018 that it had released CDER’s Manual of Policy and Procedures or MAPP, called Understanding CDER’s Risk Based Side Selection Model. FDA provided some clarification of how it is prioritizing routine pharmaceutical manufacturer inspections. However, it failed to give any information on how predictable FDA inspections will be, or did it say if the frequency of FDA drug inspections would change.

According to the agency, the Inspection MAPP is an updated effort to give manufacturers more clarity about the FDA audit process. The Inspection MAPP states that since 2005, the agency has been using a risk based metho to prioritize human pharmaceutical manufacturing inspections. Under the new MAPP, facilities that make finished drugs, in process mataerials and APIs that are used by humans, are going to be prioritized for routine inspections. Some of the factors that will be considered for prioritizing FDA inspections include:

  • The type of site for manufacturing drugs – whether it is a packager, control lab or manufacturer
  • How long it has been since the last FDA audit
  • How well the site has been in compliance
  • The history of drug inspections that have been done by foreign regulatory agencies recognized by FDA
  • How much patients are exposed
  • Any signals received by FDA about risks or hazards, such as field alert reports, MedWatch reports, and product recalls
  • Any risk of the product itself; sterility, API load, biologic drug product, therapeutic class, or emergency use drug
With these risk factors considered, the agency is going to devise a risk score for each manufacturing site to prioritize FDA drug audits. Some audits may fall outside the new risk-based structure, however. Some of the exceptions are pre-approval inspections, post-approval inspections, and for-cause inspections. Any facility that receives a OAI or Official Action Indicated classification during an audit, they will not be included in this new risk-based approach because it is necessary to re-inspect the facility to deal with the OAI. Facilities that are subject to import alerts also are not included in this risk-based structure.
Bottom Line
The Inspection MAPP provides drug manufacturers with better information about the FDA’s drug inspection programs. But there are still questions about what the drug industry should expect from FDA in the future. It is not clear at this time if this risk based system will change how often inspections occur. It has been reported that many drug manufacturers are still seeing auditors come every two to three years. Also, because FDA has been using the risk based model since 2005, this new MAPP does not state if risk factors are a statement about the existing FDA policy, or whether they are a part of a new FDA policy. So, at this time, the impact of the new FDA policy is not clear.
Also, FDA has not stated how much it is weightng the above risk factors, so drug manufacturers do not know how likely it is that a facility will be inspected in a given year. We will continue to monitor FDA statements on this new policy and will let you know what we hear.


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