Chapter Overview
In section 1 of our GMP refresher course, you will learn the fundamental principles and practices of Good Manufacturing Practice (GMP). You will discover that GMP is a set of standard industry practices that govern the development, manufacturing, testing, and distribution of safe, pure, effective, and high-quality medicinal products. You will also understand that national and international regulations, laws, and guidance underpin GMP. Finally, you will learn about the history of GMP, from its inception in the early 20th century to the present day. This section will provide a solid foundation for the rest of the course.
- Section Overview Free
- Changes to Veterinary Regulations
- Changes to Clinical Trials Regulations
- CDER Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- Risk Management Plans to Mitigate the Potential for Drug Shortages
- Non-Penicillin Beta-Lactam Drugs- A cGMP Framework for Preventing Cross-Contamination
- Update to EU-GMP Annexes
- Chapter Summary
- Quiz