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Executive Summary

CBER BIOTECH INSPECTIONS REVEAL "SURPRISING NUMBER" OF SOP DEFICIENCIES, Center for Biologics Evaluation & Research Division of Inspection & Surveillance Director Boyd Fogle told a Parenteral Drug Association/FDA Joint Conference Sept. 22 in Bethesda, Md. Commenting on a review of recent FD-483 inspection reports on 12 biotechnology firms, Fogle observed that "it is quite surprising the number of SOP [standard operating procedure] deficiencies, failure to follow established SOPs [and] failure to document discrepancies." Fogle expressed surprise that the inspections uncovered "what we consider some quite basic GMP deficiences," adding that "it really is enlightening in terms of what was originally submitted, what was designed, what was planned and then what was actually executed." The CBER director's review of 12 recent inspection reports found that 11 of the 12 firms were cited for SOP and equipment deficiencies; 10 firms had inadequate lab controls; and eight out of 12 had problems with environmental monitoring process controls. A breakdown of the different types of observations made by investigators revealed that equipment deficiencies were the leading category, accounting for 19% of the observations. Lab controls (18%), SOPs (16%) and recordkeeping (10%) were also significant problems, followed by raw materials (9%), process control (9%), environmental monitoring (7%), training (7%), storage (4%) and facility deficiency (2%). Specific examples provided by Fogle included: failure to follow the SOP for handling a spill of viable rDNA culture which occurred during the transfer of innoculent to the fermenter... deviations from specifications for WFI (water for injection) were not recorded and justified...lack of testing to determine removal of detergent residuals from fermentation vessels and other equipment...inadequate procedures to insure a product's integrity during formulation, including open vessels throughout the formulation process. Fogle's comments reiterated observations made earlier this year by CBER Consumer Safety Officer Amy Scott at a GMP conference; Scott noted that pre-licensing inspections for biologics tend to uncover procedural problems more often than product-related problems ("The Pink Sheet" March 23, T&G-14). Fogle speculated that a lack of manufacturing experience among the start-up biotech firms is responsible. He urged firms to consider "that no matter how good the design is, no matter how good your written procedures are, no matter how good your batch production records are, if the people aren't following them and there isn't a strong quality assurance program," problems will remain undetected until an FDA inspection. As part of FDA's effort to increase involvement by field investigators from its district offices in biologics inspections, the agency held a one-week national training seminar in early September that included over 40 field investigators and CBER reviewers, Fogle said. He reassured several concerned members of the PDA audience that, despite the increased involvement by field investigators, CBER would continue to take the lead role in biologics inspections.

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