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This article was originally published in The Tan Sheet

Executive Summary

VALIDATION OF CLEANING PROCEDURES GETS INCREASED FDA ATTENTION during agency inspections, FDA compliance office staffer Jay Allen told a May 25 AAPS/USP/FDA workshop on the scale-up of liquid and semisolid dosage forms in Arlington, Va. "Cleaning validation is probably one of the most current issues of concern in the pharmaceutical industry," Allen said, adding that FDA investigators "are going to take a detailed look at cleaning procedures, particularly when they involve a clean-in-place type system." Allen explained that the validation of cleaning processes will be one of the areas FDA investigators will review "during the pre- approval inspection or any type of inspection where we are covering validation." He noted that "this area is probably taking up 20-30% of the agency and industry time in the validation area." Cleaning validation is a "critical" concern, he asserted, which "has not been given the attention in the past that it really should have been." The increased FDA concern with the documentation and validation of cleaning procedures across the drug manufacturing spectrum is evident in recent FDA inspection guidances and compliance actions. [EDITOR'S NOTE: A more complete analysis of FDA's stance on cleaning validation is available in the May issue of "The Gold Sheet." Copies are available from F-D-C Reports for $ 30. (301)657-9830.] FDA's Mid-Atlantic Region Office, for instance, has developed a guide for its investigators specifically addressing current inspection concerns regarding cleaning validation. A recently revised draft of the guide was released at a May 25 meeting of the Central Atlantic States Association in Valley Forge, Penn. The Newark federal court decision reached in February on the injunction dispute involving FDA and Barr Labs has strengthened the agency's hand in enforcing cleaning validation standards. The FDA injunction action against Barr reflected recurrent inspection findings of problems with the firm's cleaning procedures, and a significant amount of testimony during the court proceedings focused on cleaning issues. The court decision generally supported FDA's interpretation of cleaning validation standards and the agency's contention that Barr had recurrently failed to meet them. As noted in the new draft of the Mid-Atlantic region guide, Newark federal court ruled in the Barr case that "a firm cannot wait for contamination and other problems to reveal inadequate cleaning procedures." In order for cleaning rules to be effective, the court stated, "the specific methods chosen must be shown to be effective." OTC drug and dietary supplement manufacturers have been included in the FDA complaints regarding cleaning procedures. For example, Sterling Drugs was issued a warning letter in September 1991 regarding production of Neo-Synephrine and other products at the firm's facility in Barceloneta, P.R. The letter alleged that the firm had "failed to implement an equipment cleaning and maintenance procedure to prevent contamination of . . . drug products." A September 1992 warning letter issued to Life-Line Nutritional Products in Hayward, Calif. asserted that the firm's equipment was "not cleaned, maintained, and sanitized to prevent contamination." For example, the letter notes, an exhaust filter "bore a thick layer of pink residues on August 24, 1992, four days after it was reportedly cleaned." FDA further alleged that Life-Line was not always following its written procedures for equipment cleaning and maintenance. Specifically, the letter maintains that the firm had not recorded the cleaning of air exhaust filters for several months previous to the inspection by FDA, "although this is required biweekly by the cleaning procedure."

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