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

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