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 online 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.
The International Conference on Harmonization (ICH) was created in 1990 with the primary aim of harmonizing the technical requirements for new drug product registration between the United States, the European Union, and Japan. It is supported by and involves regulators and pharmaceutical industry organizations from these three regions and from other countries including Canada and Switzerland. This course addresses the following:
- This online course incorporates information from the ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, November, 2005
Take Back to Your Job:
- 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.
Attendance Suggested For:
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.