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BAUSCH & LOMB INSTITUTES PROSPECTIVE VALIDATION PROCESS

Executive Summary

BAUSCH & LOMB INSTITUTES PROSPECTIVE VALIDATION PROCESS for the filtration systems at its Tampa, Fla. facility in response to a list of good manufacturing practice (GMP) deviations cited by FDA in a Feb. 7 warning letter. The warning letter resulted from an Oct. 28-Nov. 8, 1991 FDA inspection. Bausch & Lomb said it sent a written response to the agency on Feb. 12 and that all of the issues cited in the letter have been resolved. The FDA warning letter states that Bausch & Lomb's retrospective validation of aseptic filtration integrity tests showed several "problems": "use of lots manufactured on a different filtration system and with different manufacturing parameters, insufficient data on filtration integrity specifications, master formulas used to establish bubble point specifications differ from production master formulas, and products used to establish specifications are not truly representative of total production," the letter states. In its response to FDA, Bausch & Lomb said it acknowledged that a retrospective validation process was not appropriate for the filtration system. The company then implemented a prospective validation process, which FDA has accepted. No reinspection of the plant has been scheduled, Bausch & Lomb VP-Regulatory Affairs Cal Bowman said March 3. The October/November inspection of the Tampa facility was a follow-up to a partial inspection in February 1991. Bausch & Lomb said that during the initial inspection of the new facility, the agency listed several observations for improvement that were subsequently implemented by the company. The Tampa facility is intended for production of Bausch & Lomb ophthalmic pharmaceuticals, including those now produced by the company's Pharmafair subsidiary. Pharmafair recently had to recall five prescription and OTC ophthalmic drug products due to lack of assurance of sterility ("The Pink Sheet" Jan. 13, T&G-9). Several ANDAs currently are pending for Bausch & Lomb ophthalmic drugs. The warning letter states that approval of pending ANDAs "cannot be granted under existing conditions." The company said the plant is now producing only simple solutions and ointments. Bausch & Lomb announced March 16 that it had named Thomas Riedhammer, PhD, president of the Bausch & Lomb Pharmaceutical Division, which is headquartered in Tampa. Riedhammer comes to the job from Paco Pharmaceutical Services, but worked for Bausch & Lomb for ten years previously. He replaces W. Richard Clark "who has resigned from the company to pursue other interests," Bausch & Lomb said. The warning letter also calls Bausch & Lomb's microbial retention validation "inadequate." The company stated that FDA inspectors did not understand its validation protocol, which was designed by an outside contractor, because it involved a new technique. The company said that it had cleared the process with FDA's central offices, but the Tampa regional inspectors were not familiar with the protocol. After numerous discussions with the agency, the protocol and validation tests were accepted, Bausch & Lomb said. FDA also cited the company for a storage tank that was "used for a three week period without a vent filter" and a window that "was broken and repaired...with no investigation, no cause given, and no record of the steps taken to re-establish the core sterile area." Bausch & Lomb said these were documentation issues only, noting that the vent filter was in place at all times, but the appropriate form documenting that fact had not been filled out. Where the window was broken, the core sterile area was re- sterilized and validated, and supporting documentation was eventually provided to the agency.

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