ICH Q7A: Introduction and Quality Management
This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7 Guideline. This course covers the Introduction to ICH Q7 and Quality Management for API manufacture. The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients.
After this course learners will be able to recognize the purpose of the q7 guideline and how it fits in with current regulatory expectations and practices in the united states — especially in the context of the fda’s systems-based inspections program, 7356.002f. recognize the basic terminology and applications of q7 and the principles of an effective quality management system for active pharmaceutical ingredients (api) manufacture.