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Executive Summary

FDA INSPECTORS TOLD TO CLOSELY EVALUATE LAB TEST FAILURES in a quality control lab inspection guide recently prepared by FDA's Mid-Atlantic Region office. "Evaluate the decision to release lots of product when the laboratory results indicate that the lot failed to meet specifications and determine who released them," the guide advises. Noting that most manufacturers use systems that provide for test failure investigations, the guide instructs FDA auditors to request results of analyses for lots of product that have failed to meet specifications and have been retested, rejected or reworked. Through evaluating a firm's raw laboratory data and data handling system, inspectors should be able to determine how lab results are being used by management in deciding whether to release lots of the product, the guidance says. Laboratory logs and documents, when cross-referenced, may show that adverse data have been disregarded by company officials in making the decision to release product, the field office noted. The guide directs investigators to evaluate the firm's justification for so doing. Quality control laboratory practices are being evaluated by FDA as key markers for a firm's overall level of good manufacturing practice (GMP) compliance. During inspections and regulatory follow-up, FDA is making it clear that it considers good QC lab procedures to be a pivotal GMP area. Increased scrutiny of QC labs has resulted in a marked upsurge in the number of laboratory practice deviations cited in FD-483 inspection reports. Prominent among those citations has been the failure of firms to document and/or justify adequately the decision not to take action on failing laboratory test results. An inadequate response to lab evidence of process and product problems, in turn, has been a common denominator in recent FDA enforcement actions. A May warning letter to Wyeth-Ayerst, for example, highlighted FDA's concern that lab management at the firm's Guayama, Puerto Rico facility failed to adequately evaluate test data before product was released ("The Pink Sheet" June 15, T&G-12). FDA officials describe one aspect of lab problems as "testing products into compliance." The agency is finding that some firms test in-process and finished products until they pass the tests. Those products are then released without adequate explanation or documentation of why the failing results were dismissed. The inspection guide emphasizes that the QC lab "serves one of the most important functions in pharmaceutical production and control, and a significant portion of the GMP regulations pertain to the quality control laboratory and product testing." In turn, the guide states, "laboratory records and logs represent a vital source of information that allows a complete overview of the technical ability of the staff and of overall quality control procedures." The guide notes that the pre-approval audit should include a comparison of raw laboratory data, procedures and equipment relevant to the bio/clinical test batches with the information on those batches filed in the application. The overall objective for the laboratory inspection, FDA says, is to ensure that the data used to support applications and product release is accurate, reliable and timely. As such, field office management is directing its inspection teams to focus on raw lab data and the firm's system for controlling it. Ultimately, the FDA guide asserts, the standards met by the lab will depend on the training of the lab personnel and quality of the supervision. The guide emphasizes that "in most cases, significant violations of GMP regulations are the direct result of lack of proper management of the laboratory staff and its work." [EDITOR's NOTE: A more detailed analysis of FDA inspection activity in the QC lab area is contained in the July 1992 issue of "The Gold Sheet," a monthly publication covering drug quality control issues. Individual copies are available from F-D-C Reports (Tel.: 301-657-9830) at $40 for non- subscribers.]

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