1990 Annual Report

QI TALITY CONTROL SECTION Committees of the Quality Control Section worked closely with the U.S. Pharmacopeia (USP) on compendia requirements for pharmaceutical products. Specific topics included water requirements, impurities in drug substances, dissolution test calibrators and aerosol dosage forms. In addition, the Section Advisory Committee revised and updated the PMA statement on Principles of Total Control of Quality in the Drug Industry for distribution to PMA members. Section representatives participate on 20 technical committees, addressing such issues as aerosol dosage forms, stability testing, dissolution testing, statistics and biotechnology products. Section members also participate on several joint projects with representatives of other technical sections, including projects dealing with sterilization issues; computer system validation; water quality; impurities in bulk drug substances; and vendor certification. Quality Control executives, chemists, pharmacists and other scientists participate in the Section. 1990-91 CHAIRMiAN Donald R. Daoust, Ph.D. Carter-Wallace. Inc. PMA STAFF LIAISON Thomas X. White Assistant Vice President Manufacturing & Quality Control PIA BOARD LIAISON Herbert Sosman RESEARCH AND DE VELOPMENT SECTION 1990-91 CHAIRIIA\ Ralph E. Christoffersen, Ph.D. SmithKline Beecham The Research and Development Section continued to work with the FDA to improve the review of New Drug Applications through the development of Computer-Assisted New Drug Applications and the use of project-management techniques. The Section developed a number of papers on scientific issues- including interim analysis, racemic mixtures, the Draize test and enantiomerism in the drugdevelopment process. The Section also developed a White Paper on Technology Transfer, organized a joint PMA/National Institutes of Health Technology Transfer Conference, and established a committee to consider how the industry might be able to help combat drug abuse. The Section, which is led by a Steering Committee, considers such matters as research management, scientific information management, new techniques in drug development, and the biochemical, toxicological, pharmaceutical and regulatory problems associated with the development of new products. Research directors, chemists, pharmacists, pharmacologists, toxicologists, biologists, physical chemists, biostatisticians and other scientists participate in the Section. PMA STAFF LIAISON PtlA BOARD LL4ISON C. Vance Gordon Theodore Cooper, M.D., Ph.D. Assistant Vice President for Researcn, and Derelopment 26

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Title
1990 Annual Report
Author
Pharmaceutical Research and Manufacturers of America
Canvas
Page 26
Publication
Pharmaceutical Manufacturers Association
1990
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reports
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reports

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"1990 Annual Report." In the digital collection Jon Cohen AIDS Research Collection. https://name.umdl.umich.edu/5571095.0504.028. University of Michigan Library Digital Collections. Accessed June 10, 2025.
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