Niagra Pharmaceuticals, Flamborough, Ontario, Canada, Feb. 23 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

The firm, a manufacturer of an eyewash solution that contains purified water, was determined to have deviated from GMPs covering the manufacture of sterile drug products.

For example, the company's eyewash solutions are sterilized by irradiation, which by FDA's definition makes them new drugs. This means the products must have a current NDA.

FDA also noted that the firm's testing of each batch of drug product for distribution did not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. Testing should continue to be completed prior to release unless alternate release methods are provided for in an approved application.

Next, Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.

Further, written production and process control procedures were not followed in the execution of production and process control functions and were documented at the time of performance.

FDA acknowledged that the firm updated the batch production records; however, the revised records did not adequately correct the lack of documentation of certain steps. NDA; Stab; Val; Doc. 14095W

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