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Executive Summary

WATER PURIFICATION SOPs SHOULD INCLUDE UP-TO-DATE PRINT of the system, FDA New York region drug investigation specialist Henry Avalone told industry representatives at an agency-sponsored workshop on high purity water held in Cranford, N.J. May 15. During an inspection, Avalone said, the FDA investigator will normally want to review the print to help identify potential problem areas such as slopes, drops and dead legs, and then inspect the piping following the print to make sure that it is accurate. Lack of an up-to-date print, Avalone warned, would usually be noted on an FD 483 observation report following the inspection. For example, he said, recent FD 483s have cited firms for failure "to contain a print with particular valves and piping identified," and for failure to update the print to include "additional outlets, repiping, filter and tank modifications completed within the system since the current drawing" was made. Avalone explained that lack of an adequate print would bring into question the firm's procedures for review and validation of the system, and the ability of the quality control manager or microbiologist to know where to sample. "In those facilities I have seen without updated prints," the FDA investigator told the workshop, "serious problems in these systems were identified." The FDAer told the workshop that in spite of the agency's efforts to publicize the problems and to inform drug mfrs. of what their procedures should include, agency investigators are still encountering basic problems in the water purification systems and tracing recalls back to such problems. Drug Quality Compliance Division staffer Terry Munson emphasized at the meeting that a firm's water purification system standard operating procedures (SOPs) also should clearly identify the decision criteria for taking action when sampling indicates that the limits for microbial contamination in the system have been exceeded. "If you exceed the action limit, what are you going to do? We like to see it spelled out," Munson noted. Munson explained that an investigator would look to see what a firm did at the time microbial counts may have exceeded the action level. "We would like to see that you produced a report saying here's what we did in accordance with the SOPs," Munson maintained. "We like to see the decision criteria spelled out in the SOPs, so that everybody knows exactly what's coming about."

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