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PARKE-DAVIS OVERSIGHT FOR COPANOS ORAL ANTIBIOTIC PRODUCTION

Executive Summary

PARKE-DAVIS OVERSIGHT FOR COPANOS ORAL ANTIBIOTIC PRODUCTION is stipulated by a Nov. 4 consent order between Copanos and the govt. The order, entered in Maryland Federal Court, states that appropriate members of a Parke-Davis quality control team should oversee the production, laboratory testing, and recordkeeping related to oral antibiotic operations at Copanos. The order further calls for Copanos employees to "comply with the suggestions and directions of all members of the P-D quality team." The P-D supervision must remain in effect, the decree states, until Copanos submits to FDA "a written list of each supervisory person who will be engaged in manufacturing such drugs and his (their) qualifications, the FDA approves such person(s) in writing, and such approved person(s) is (are) supervising the manufacture of such drugs." FDA is setting up P-D as a quality control surrogate for Copanos production. The consent decree formalizes an existing arrangement between P-D and Copanos for P-D oversight when the firm uses Copanos as a contract manufacturer for its oral antibiotics. The Nov. 4 consent order also clears the way for Copanos to resume production of its injectible drug manufacturing operations, which produce mainly veterinary drugs. The order follows a November 1984 agreement with FDA that certain prescribed changes in Copanos GMP-related activities would be made. The consent order puts in writing certain GMP requirements for Copanos, several of which relate to the firm's recordkeeping activities. For example, it specifies the need for actual yields and percentages of theoretical yields to be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the drug product. Such calculations, the decree states, "shall be performed by one person and independently verified by a second person, and shall promptly and physically be incorporated in the batch record."
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