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Executive Summary

LYPHOMED IS COMPUTERIZING LOT REVIEW RECORDS in order to meet annual product review requirements from FDA. LyphoMed reported the quality control move in response to a recent FD-483 report issued by Chicago district investigator John Bruederle, which alleged that the firm's annual product review reports were incomplete in several areas. LyphoMed said it plans "to set up a computer program for the annual review, which will eliminate all of the situations pointed out by the investigator." FDA investigator Bruederle maintained that LyphoMed's summary reports of its annual product reviews "failed to document that all measurable [batch] parameters were actually evaluated." For instance, the FD-483 report states, "some quality control tests are not recorded on the product review forms and are, therefore, not included in the written summary." The annual product reviews were also found to be incomplete by the FDA investigator in failing to evaluate and record stability data and manufacturing discrepancies. In addition, Bruederle maintained, "data listed on the product review forms is not recorded in a format that facilitates the identification and evaluation of transitory problems or trends." Bruederle also noted that written summaries "lack sufficient information to evaluate potential problems or to present a meaningful interpretation of the data summarized from the product review forms." Annual product review reports was one of several GMP problem areas addressed by the FDA investigator following a routine inspection completed in July of LyphoMed's Melrose Park, Ill. plant last July. Minor deviations were also observed in the firm's procedures regarding determination of product fill volume, media filling and microbiological testing in lyophilizer validation, handling of stability test samples, and asceptic practices by employees. The FDA investigator noted in the FD-483 that a few vials of LyphoMed's injectable products did not meet USP standard deviation specifications for content uniformity. The lots in question, Bruederle reported, were released following visual inspection. He informed LyphoMed that USP "does not provide for visual inspection as an alternate means of verification of quantity of contents." LyphoMed indicated in its response to the FD-483 that it was modifying its procedures to include a weight check of samples collected after the visual inspection is performed.

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