US FDA revised MAPP on cGMP Surveillance Inspections
The US FDA’s CDER revised the Manual of Policies and Procedures (MAPP) on managing surveillance inspections based on its Site Selection Model. The CDER staff uses this model to prioritise manufacturing sites for national and international routine quality-related cGMP surveillance inspections.
The 2023 version has been effective since 26 June 2023. It was amended in terms of quality system effectiveness and introduced a new risk factor related to the compliance history of establishments in the country or region in which the establishment is located. This includes the history of violations related to products exported from such country or region that are subject to such regulation.
The risk factors of patient exposure (e.g., to the Coronavirus) and the inherent product risks introduced in 2018 are further clarified. Inherent product risks are associated with the product itself, e.g., dosage form, how the drug is administered, or the therapeutic class.
The following types of sites are excluded from prioritisation under this MAPP:
- Human drug compounding outsourcing sites registered under section 503B of the FDCA
- Medical gas sites, (as a separate selection process manages these)
- Excipients (however, these may be inspected when deemed necessary)
- Drugs intended for use only in clinical trials (however, these may be inspected when deemed necessary)
CDER’s Manual of Policies and Procedures (MAPPs) are federal directives and documentations of internal policies and procedures. MAPPs are required by law and made available to the public to make CDER a more transparent organization. The yearly CDER report on the state of pharmaceutical quality summarises and analyses the inspection findings. Link to CDER report for the fiscal year 2022.