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Ensure GMP Sites Are Ready for FDA Audits to Avoid Delay in ANDA Approval
(Thursday, June 20, 2024) The FDA has set rules under the GDUFA III commitment for how to handle a facility’s readiness for inspection for ANDA applications, which affects the goal date for an application. A new FDA Guidance Document released this week provides a simpler breakdown of these rules. Applicants must list their manufacturing sites and their contact info in the ANDA (Abbreviated New Drug Application or generic drug approval application). When filling out Form FDA 356h, applicants must ensure the facility information is correct. Before marking a facility as ready for inspection, applicants should check that the facility operations, methods, and product formulation match what’s in the application. Data at the facility must be complete and accurate, aligning with the application. The facility must be ready for commercial manufacturing at the time of filing the ANDA application. The FDA uses a specific inspection program to check these criteria. Applicants can use the FDA’s guidance document, "Good ANDA Submission Practices," for more advice on assessing facility readiness. Sometimes, facilities don’t know they are listed on Form FDA 356h. This can lead to being unprepared for inspections. Applicants should tell each facility that they are listed on the form and whether they marked "yes" or "no" for inspection readiness in Field 28. When signing the form, applicants certify that the information is complete and accurate. Incorrect information can delay or lead to the rejection of the application. Use Form FDA 356h to provide information about the facilities involved in manufacturing, packaging, and control of drug substances and products. Applicants must check "yes" or "no" in Field 28 to indicate if each facility is ready for inspection. Do not use the "N/A" box for original ANDA submissions; use it only if a facility is withdrawn from the application. If Field 28 is left blank or incorrectly marked "N/A," the FDA will ask for clarification. If there's no response within the given time, the application gets a default 15-month goal date. When an ANDA is submitted with a completed Form FDA 356h, the FDA checks for facility readiness. If everything is in order, they set a goal date and send an acknowledgment letter. If any facility isn’t ready for inspection, the FDA assigns a 15-month goal date and delays further assessment until an updated form shows all facilities are ready. Once an amendment is submitted showing all facilities are ready, the FDA reassigns a standard or priority goal date based on the amendment’s receipt. To make the reassignment process smoother, applicants should include “Facility Ready For Inspection” and the ANDA number in the cover letter. If the amendment isn't submitted 30 days before the original goal date, the FDA will reset the goal date to 30 months from the original submission date and start the assessment. The FDA aims to complete 90% of such ANDAs within 30 months of the original submission. The FDA's process involves checking facility readiness to ensure applications are accurate and facilities are prepared for inspections. Accurate and timely submission of Form FDA 356h is crucial to avoid delays. Proper communication and updating of information are key to meeting the FDA’s requirements and achieving timely approval. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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