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The Canadian pharmaceutical industry includes a diverse range of manufacturers, research organizations, third party testing organizations and governmental bodies. In this course the landscape of this industry from a North American perspective will be discussed, along with the departments which make up a pharmaceutical company. The development, approval process, formulation, manufacture and testing of solid dosage forms (tablets, capsules, and powders) will be the focus. Pharmacopeia methods and their role in the industry will be discussed. The laboratory portion of the course will address the testing of raw materials, finished products, and their stability using chemical and physical testing methods according to USP/NF monographs and "in house" methods. The importance of documentation, data integrity, and Good Laboratory Practice (GLP) in the laboratory is stressed.
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