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EXCIPIENT INTERNATIONAL STANDARDS: FRESH START URGED IN DEVELOPMENT

Executive Summary

EXCIPIENT INTERNATIONAL STANDARDS: FRESH START URGED IN DEVELOPMENT of harmonized standards for non-active pharmaceutical ingredients by participants at an international conference in Orlando, Fla. Jan. 30-Feb. 1. Summing up the meeting discussion on harmonizing monographs for the non-active pharmaceutical ingredients, British Pharmacopoeia Commission Scientific Director Alan Rogers pointed to agreement that a "zero-base approach" was appropriate. "Rather than just trying to merge what is in the pharmacopeias at the moment," Rogers said, "it seems worthwhile to look at the monographs afresh. " Because excipient monographs have not received much attention recently from the pharmacopeias and may not reflect current technology or requirements, conference participants agreed that the harmonization process presented a good opportunity for needed improvements in the standards. Rogers suggested that monographs should be developed by taking the approach: "if we were starting to write this monograph in 1991 what would we put into it." The Orlando conference, cosponsored by the U.S., British, European and Japanese Pharmacopeias, followed a "mini-conference" held at USP headquarters in Rockville, Md. in October focusing specifically on lactose and magnesium stearate. The meeting, which included the participation of several major manufacturers of the two excipients, was directed at developing acceptable common monographs for the products. Based on discussions at the October meeting, draft monographs were drawn up for further review at the Orlando conference. [EDITORS' NOTE: For additional coverage of the Joint Pharmacopeial Open Conference on International Harmonization of Excipient Standards, see "The Pink Sheet" Feb. 4, p. 8.] A second joint pharmacopeial conference, planned for 1992, will focus specifically on standards for biotechnology products. Another "mini-conference" is also planned for this summer at USP on microcrystalline cellulose, to be followed by one on pharmaceutical-grade water. The excipient area is getting heightened attention as a potential starting point or model for harmonization across broader drug regulatory lines. A conference on harmonizing technical requirements for drug product registrations is scheduled to be held in Brussels in November. The conference will give separate attention to harmonization issues involving drug quality, efficacy and safety. Abbott Labs Corporate Purchasing Director Roy Kerr maintained at the Orlando conference that lack of consistent and complete standards for excipients has been a "nemesis" for multi-national drug companies. International harmonization of non-active ingredient standards would benefit manufacturers, Kerr maintained, by lowering production costs, reducing approval time for new products, and increasing the latitude that scientists and purchasing departments would have when developing new products or changing the excipients in existing products. Cost reductions resulting from a more complete and harmonized international monograph system, Kerr said, would include reduced R&D time, reduced quality control testing, and increased manufacturing productivity.
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