The impact of FDA’s foreshortened inspection classification timelines, as prescribed by the second installment of the Generic Drug User Fee Act (GDUFA II), will include placing additional weight on the quality of the 15-day inspection responses, agency compliance officials are noting.
GDUFA II calls for surveillance inspections to be classified within 90 days of their conclusion.
In addition to driving faster responses when inspections reveal significant GMP concerns, the shorter turnaround time is intended to provide application sponsors with more timely knowledge of the status of the sites they are considering using in their applications.
Addressing the impact of the new timelines at the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference held in Arlington, Virginia in June, Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) Office of Manufacturing Quality (OMQ) Director Tom Cosgrove noted that the agency’s goal is to achieve implementation as soon as feasible – and well ahead of that deadline.
FDA has developed a “concept of operations” (ConOps) intended to more closely integrate the review and inspection processes and related compliance activities [For an in-depth review of ConOps and its implications, see IPQ October 23, 2017.] To reach the 90-day objective for inspection classification, ConOps calls for the Office of Regulatory Affairs (ORA) to provide CDER with the final report and classification recommendation within 45 days, leaving CDER 45 days to make the final classification and issue it to the facility owner.
ConOps then provides a six-month goal date from inspections for compliance action follow-up, such as warning letters, that arise from “official action indicated” (OAI) classifications.