ICH Q7A: Resources and Materials Management

This is the second in a series of courses designed to instruct on Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers qualifications for personnel, requirements for buildings used in API manufacturing, considerations for API manufacturing equipment, and materials management. Learners should have a working knowledge of current GMPs for drug products as set out in CFR 21 Parts 210 and 211. Learners should also have a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients. Learners should have completed the course ICH Q7A: Introduction and Quality Management.