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STANDARD OPERATING PROCEDURES DEVIATIONS ARE MOST COMMON GMP PROBLEM

Executive Summary

STANDARD OPERATING PROCEDURES DEVIATIONS ARE MOST COMMON GMP PROBLEM in European and Japanese firms, William Troetel, PhD, told FDA staff at a Dec. 10 seminar. Troetel is senior VP-regulatory affairs for Oxford Research International, a Clifton, NJ-based consulting firm that aids European and Japanese firms in meeting FDA's requirements during the drug development process. "The most problematic area, without doubt, is the problem relating to written standard operating procedures (SOPs)," Troetel said. "Pharmaceutical firms in European and Japan have a real problem [with SOPs]. They have SOPs to some extent, [but] they do not have adequate numbers, [and] the SOPs are not in the kind of detail that we like to see when we review documents for the personnel working in the facility." Generally, Troetel added, "the SOPs are undated [and] unsigned." Troetel noted that the second most common deviation from FDA's good manufacturing practices [GMPs] is "usually in the master production record and in the batch production record." In Europe "especially," Troetel said, "I frequently find that the master production record is a formula written in a notebook and that the batch production record is very often just a hand copy or protocopy of the formula." Troetel added that "sometimes the formula is correct, [but] sometimes it isn't." Troetel emphasized that adherence to FDA's GMPs and good laboratory practices has become increasingly important to Japanese and European pharmaceutical firms as those companies attempt to bring drug products further along in the development process for licensing to U.S. companies. The consultant noted that FDA's increased acceptance of foreign data has contributed to the European/Japanese drug firms' interest in developing pharmaceutical drug products up to the NDA stage. Troetel stated that many foreign drug firms are interested in having FDA inspect "facilities that are going to be built [and] facilities that are already being used but not having materials sent to the U.S." He acknowledged that "it's a very difficult request [since] the FDA is not in the habit of inspecting firms just on a consulting basis." Citing the budgetary concern in providing such a service, Troetel suggested that the agency recover costs for the inspections by charging the foreign firms. Referencing budget restrictions, one FDA staff member commented that agency inspections of foreign clinical investigators would make him more accepting of clinical trial data generated outside of the U.S. He said: "As a reviewer of clinical data, I have . . . problems with accepting clinical data [because] we have no way of auditing [the investigators]." He explained that he is "concerned because we have a number of investigators in this country who are disqualified" from NDA studies.
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