FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs

Regulatory NewsRegulatory News | 17 October 2022 |  By 

The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP) surveillance inspections.
 
The updates reflect FDA’s use of alternative tools for evaluating facilities in lieu of onsite inspections, tools that were heavily relied upon during the pandemic, as well as newly added sections covering nitrosamine risk assessments, and the incorporation of International Council for Harmonization (ICH) guidelines. Both CPGs went into effect on 17 October.
 
In the CPG for PAIs, 7346.832, the agency uses four criteria for deciding whether to conduct a PAI: these include a firm’s readiness for commercial manufacturing, whether the firm has conformed to the application, whether there are data integrity problems, and the firm’s commitment to quality.
 
The revision also incorporates the ICH Q10 guideline on pharmaceutical quality systems, the ICH Q12 guideline on postapproval changes, and addresses nitrosamine risk assessments.
 
The revision also formalizes the agency’s practice of using alternative tools to conduct PAIs, including the use of inspection reports from trusted foreign regulatory partners through mutual recognition agreements (MRAs), the use of remote regulatory assessments (RRAs), requesting records and other information directly from facilities and other inspected entities or using remote interactive evaluations (RIEs).
 
Lastly, the CPG has been amended to address a goal in the Prescription Drug User Fee Act (PDUFA VII) commitment letter requiring FDA to communicate its intent to provide at least 60 days in advance of a PAI.
 
The CPG replaces an earlier version issued in 2020. (RELATED: FDA Updates Compliance Guide on Pre-approval Inspections for Drugs, Regulatory Focus 7 January 2020)
 
The CPG for routine GMP surveillance inspections, 7356.002, is meant to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.”
 
The guideline has been revised to add elements of the ICH Q9 guideline on quality risk management, ICH Q10 on pharmaceutical quality systems and ICH Q12 on postapproval changes. It also adds a new section on evaluating a firm’s control of nitrosamine impurities; as well as FDA’s use of alternative tools for evaluating facilities.
 
FDA CPG on PAIs under 7346.832
 
FDA CPG on GMP inspections under 7356.002

 

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