This course is an introduction to the methods related to the production of pharmaceuticals. Several dosage forms such as solids, liquids, semi-solids, and parenterals are discussed. In each, the merits of the type, composition, handling, processing, testing and equipment used are discussed to provide a foundation from which more specific training can be undertaken. Regulatory requirements which serve as controls, as well as the rationale which support their application are discussed and applied to areas of plant operations. (Lecture only)

This subject introduces students to the fundamental pharmacological aspects of drugs and their interaction with various types of cells. Topics include routes of drug administration, factors affecting drug absorption and mechanism of action. Specific drugs for the central and autonomous nervous systems as well as the cardiovascular system are studied. Drugs for the endocrine system, therapeutic monitoring system and antiallergics, antihistaminics are also covered. (Lectures only)

This course describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the "submission process" - the regulatory requirements at the various stages in a drug product's development from inception through IND (Investigational New Drug) and NDS (Notice Of Compliance). The functions of relevant divisions of the Health Protection Branch are discussed. Also covered are: DINs (Drug Identification Numbers), Provincial Formulatory Submissions, drug labelling and drug advertising, SOPs (Standard Operating Procedures), compliant handling (including Adverse Drug Reactions), recalls, Plant Master Files (PMF), Drug Master Files (DMF) and regulatory inspections. (Lecture only)

This subject focuses on product development and registration in Canada. Students learn, and get a hands on approach to prepare a high quality clinical trial application (CTA), including generic and brand submissions. Emphasis is on the mechanics of preparing submissions in the Common Technical Document (CTD) format in Canada. Specifically, this subject clarifies the rules, regulations and guidelines on how submissions are prepared, and how deficiency letters are addressed to TPD. An overview of the e-CTD modules is provided in detail. (Lectures Only)

This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in USA, European countries, Japan and MENA region are examined as well as the regulations in a selected number of other geographic locations. Drug submission requirements based regulations in these countries are compared.

This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. A) It focuses on the design of proper quality control/quality assurance systems to ensure the manufacturing of safe products and also to satisfy regulatory authorities. All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product. B) It focuses on the management of the quality assurance systems to provide sufficient and adequate records on all testing distribution and all other procedures that must be in place. (Lecture only)

This course is an overview of the various aspects of validations, qualification/validation of pharmaceutical systems, processes and equipment. These processes received acceptance by the pharmaceutical industry in the late 1970s to ensure current Good Manufacturing Practices (cGMP) and product quality and integrity. Reliance upon end-product testing is insufficient to assure product quality. A high degree of quality of assurance arises only from good product and process design, validation and process controls. Validation concepts are applicable to both oral, solid dosage forms and sterile manufacturing pharmaceutical facilities. (Lecture only)

This subject is designed as a continuation of PFT501- Pharmaceutical Manufacturing Methods, teaching advanced pharmaceutical dosage forms in respect to design, development, techniques and technology involved. The processes and methodology involved in manufacturing of different dosage forms are compared in the following perspectives: equipment, benefits and appropriate application. (Lecture only)

This subject focuses on the concept of quality assurance and the contributions of quality assurance in a pharmaceutical organization. It takes a snapshot examination of common quality applications, tools, processes, and systems relevant to the pharmaceutical industry. Topics covered include: foundations of quality, basic statistical concepts and applications, document systems, SOPs, quality audit, validation, ISO standards, GMPs (FDA and HPFBI), product recall and complaints handling.

This course deals with experimental investigation and evaluation of many kinds of package containers such as glass, plastic, metal and paper, closures, liners, and rubber stoppers. Topics include testing methods, development of quality control methodology, legislative influences on packaging technology, and the role of the package in marketing. (Lecture only)

This course examines the organizational role, responsibilities and requirements of the Health Canada related to the production, labelling, selling, and advertising of drugs, radiopharmaceuticals, biologics, natural health products and medical devices in Canada. A review of USA and EU laws and regulations is also covered. (Lecture only)

This course covers the physical and chemical factors considered important in the formulation of effective and safe solid dosage forms. (Lecture only)

This course covers the principles of contamination control in pharmaceutical manufacturing. Topics include: basic microbiology, government regulations related to contamination control, microbial control of contamination in manufacturing, air filtration, ventilation, purification and control of water system and water testing for pharmaceutical manufacturing, production hygiene, employee health and hygiene requirements, microbiological testing of environment and interpretation of critical test results, evaluation of disinfectant and cleaning validation, self inspection and training of production employees for contamination control. (Lecture only)