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Executive Summary

FDA INSPECTION PROGRAM EMPHASIZING PURIFIED WATER SYSTEM VALIDATION will begin within the next few months, FDA compliance safety officer Terry Munson told a recent Proprietary Assn. (P-A) seminar on manufacturing controls in Philadelphia. Since "many mfrs. do not know how to or cannot consistently produce purified water that is microbiologically acceptable," the agency "is starting a new inspection and sampling program to assess the industry's ability to manufacture OTC topical and oral drug products," Munson said. Investigators will be looking "at every aspect of the manufacturing process, especially purified water systems." The FDA staffer stressed that use of preservatives in products manufactured with water does not obviate the need for careful scrutiny of the water system. "We have seen too many instances where organisms resistant to the preservatives show up all of a sudden or the preservative system is overpowered by the sheer number of organisms present. FDA will not accept this argument as a reason for not recalling products manufactured with water from a contaminated or unvalidated water system." Munson said that 65%, or 18 of the 28 recalls for microbial contamination for the past two years, were traced by the agency to lack of validation of the purified water system. Antacids have been the main problem category, but some OTC topical products, mainly lotions, were also recalled, Munson reported. The FDAer noted that most of the recalled products contained preservatives. In addition, Munson said, FDA has "issued regulatory letters and seized products for lack of validation of purified water systems." Munson cautioned that USP's limits on when to reject water quality in pharmaceutical manufacturing are not as stringent as FDA's good manufacturing practices (GMP) standards, and that the agency would take regulatory action against mfrs. that adhered to the USP but not the GMP standards. The microbial count limit for sterile water for injection is 50 colony-forming units per ml. according to USP v. 0.1 units per ml., according to FDA. USP's reject limit for purified water is 100 units per ml. v. FDA's limit of 50 units per ml. In addition to the total microbial count limit for purified water, Munson said, "there should be a specification of no pseudomonas species present."

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