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Executive Summary

PAR "VOLUNTARY DECLARATION" CALLS FOR CONTINUOUS REVIEWS of the generic firm's manufacturing, quality control, R&D functions, training programs and organizational structure. In an April 19 release, Par announced that it has initiated a "Voluntary Declaration" to ensure tht its "operations comply with both its approved products applications and current Good Manufacturing Practices requirements." The company noted that FDA helped draft the declaration and supported the idea of the company articulating its commitment in writing. The declaration requires "comprehensive and continuous reviews to be conducted by Par in a number of areas including: batch reviews for compliance with approved applications, [and] audit of manufacturing, quality, laboratory, research and development, and regulatory affairs functions," the release says. The plan also calls for continuous review of "standard operating procedures and documentation control, training, organizational structure, and process/product validation." The declaration does not involve Par's subsidiary, Quad Pharmaceuticals, which recently recalled a number of products for not conforming to the specifications of their ANDAs. Par has been in the process of reintroducing or recalling drugs as it reviews each of its products on a case-by-case basis through an internal audit. The firm halted distribution of all solid oral dosage form products in August while it reviewed the corresponding ANDAs. The audit was undertaken following an FDA inspection that uncovered manufacturing deficiencies and falsification of data. In the release, Par noted that the declaration is expected to help the company "to more effectively reintroduce" those products still under review. * In a separate action, Par appointed Elie Shami, PhD, to senior VP-scientific affairs and quality and to the board. Shami's position is a new one, combining a number of responsibilities held by former Par executives. Shami previously held senior positions in several drug companies, including Orlove Research and Development Group, Superpharm, DuPont, and SmithKline Beecham. Most recently, he was head of R&D activities at Orlove Research and Development Group.

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