"Ensuring the Safety of Pharmaceutical Products" |
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Speaker: | Dr. Sharon J. Northup | |
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Northup
RTS (Regulatory Toxicology Services) Highland Park, IL. | ||
Date: | Friday, January 14, 2005 | |
Location: | The Parthenon Restaurant
(Same as the main meeting) |
Job Club: 5:00-6:00 P.M.
Topical Group: 5:30-6:30 P.M.
Social Hour: 6:00- 7:00 P.M.
Dinner: 7:00 P.M.
Meeting: 8:00 P.M.
The quality of pharmaceutical products is of concern to all individuals, regulators and health care practitioners. This presentation will review the development of standards for pharmaceutical products and their integration into the product development process.
The development of standards for the quality of pharmaceuticals marketed in the United States began on October 3, 1805, when the Massachusetts Medical Society decided that a pharmacopeia was necessary “to secure a uniform mode of compounding medicines.” This evolved into the development of a national pharmacopeia and the publication of the first US Pharmacopeia in 1820. That first pharmacopeia contained a primary list of 221 drugs, a secondary list of 71 drugs and 329 preparations and compositions. The 2004 US Pharmacopeia contains approximately 3200 monographs on the identity, strength and quality of pharmaceutical drugs and dietary supplements.
Standards for the purity of generic products vary significantly. Variables include the type of drug, method of preparation, formulation and the date of revision of the standard. In general, a drug monograph reflects the quality properties of the first proprietary product when it goes off-patent. New information on manufacturing methods or new quality standards necessitates revisions of older monographs.
The methods of drug substance synthesis
and product formulation have a significant affect on purity. Drugs prepared
via chemical synthesis, generally, have fewer impurities than those prepared
from microbial or mammalian cell fermentation. Improvements in chemical
analytical techniques have contributed significantly to controlling and
reducing the impurities of drug products.
Dr. Northup, a certified toxicologist, has a consulting
practice in the safety and toxicology of pharmaceutical and medical products.
She is actively involved in developing volunteer and regulatory product standards
through the US Pharmacopeia, ASTM (American Society for Testing and Materials),
AAMI (Association for the Advancement of Medical Instrumentation), and ISO
(International Standards Organization).