ICH Q7: 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 Q7 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 Q7: Introduction and Quality Management.

After this course learners will be able to identify the general requirements for qualification of api manufacturing personnel. identify the requirements for buildings and facilities as well as api manufacturing equipment. recognize materials management and warehousing and distribution procedures.