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…
