In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm).
The Center for Drug Evaluation and Research (CDER) issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1, Understanding CDER’s Risk-Based Site Selection Model, as provided by the Office of Pharmaceutical Quality and effective September 26, 2018. MAPP 5014.1 can be found here.
The MAPP provides clarity on what many of us had surmised that in conducting a risk based inspection approach that inspection history and recall history as well as the dosage form of products (i.e., sterile injectables as the highest risk) weighed heavily on FDA’s decision to inspect sites more frequently. Dr. Gottlieb’s posting also provides insight into the point that location of a facility alone is not the basis for inspection frequency. FDA is similar to industry in the need to both ensure quality of products and thus patient safety and balance resources. The released policy does just that in ensuring FDA’s inspections are prioritized based on potential risks to patients. As taken from the MAPP: –
The Site Selection Model will use risk factors consistent with section 510 of the FD&C Act. This provision identifies specific risk factors and allows FDA to determine additional ones, as follows:
- a) The compliance history of the establishment.
- b) The record, history, and nature of recalls linked to the establishment.
- c) The inherent risk of the drug manufactured, prepared, propagated, compounded, or processed at the establishment.
- d) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 704 within the last 4 years.
- e) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 809.
- f) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.
A risk score will be generated for each site. The scoring is based on either empirical evidence collected by FDA, subject matter experts’ judgment, or a combination of both. The MAPP also allows for refinement of scoring criteria as a mechanism of continuous improvement. The scores will be used to generate a Site Selection Inspection List (SSIL) that prioritizes sites for surveillance inspections.
There is one caveat to the MAPP – that site selection is for routine surveillance inspection scheduling and not other inspection types for preapproval or post approval changes or for-cause.