QA102 Current Good Manufacturing Practices (cGMP) — Quality Systems Part 1

cGMP stands for Current Good Manufacturing Practices, which are a set of regulations and guidelines established by the United States Food and Drug Administration (FDA) to ensure the quality, safety, and efficacy of pharmaceutical products, medical devices, and food products.

The regulations apply to all aspects of production, including the design, construction, maintenance, and operation of manufacturing facilities, as well as the production process itself. cGMP also covers testing and quality control procedures, documentation, and record-keeping requirements.

Compliance with cGMP is required by law, and failure to meet these requirements can result in regulatory action, including product recalls, fines, and legal action.

This course is intended to provide learners with principles and practical implications of cGMP in the pharmaceutical and biopharmaceutical industry. The design of a proper quality control/assurance system to ensure R&D, manufacturing, and marketing of safe pharmaceutical products as well as meeting regulatory requirements will be described. Learners will gain significant hands-on experience with all cGMP systems, from the R&D stage to product launch and sales.

Learning Points:

• Quality and FDA cGMP
• Quality Management Systems
• Organization and Personnel
• Building and Facilities – Water, Air Systems, Maintenance, and Sanitation
• Equipment – Design, Maintenance, and Operation
• Quality Control Laboratory and Testing