This course describes the development, approval process, formulation, manufacture and testing of pharmaceutical products. Solid dosage forms will be the focus (tablets, capsules, powders), liquid dosage forms (solutions, syrups, suspensions, emulsions) and other dosage forms (ointments, creams, transdermal patches, aerosols) are briefly addressed. The pharmaceutical industry is addressed from a Canadian and North American perspective. The role of non-government and government agencies (USP/NF, FDA, CDER, TPD) is discussed. GMPs and GLPs are described as they relate to this industry as well as Quality Assurance and its role in helping to establish/maintain quality standards. The Laboratory portion of the course addresses the testing of raw materials and finished products. Both chemical (impurity testing, assays – HPLC, UV/VIS, and identification tests) and physical testing (friability, disintegration, dissolution, viscosity, hardness, etc.) are performed according to USP/NF monographs and "house" procedures. The importance of documentation and Good Laboratory Practice (GLP) in the laboratory is stressed.