The pharmaceutical/biotech industry is governed by various laws and regulations in the U.S. and other countries with respect to Good Clinical Practices (“GCP”), Good Manufacturing Practices (“GMP”), and Good Laboratory Practices (“GLP”) (collectively, “Good Operating Practices” or “GxP”), among other practices.

It is Amgen’s policy to comply with all applicable laws and regulations regarding its research, development and manufacturing activities, including GxP. This Policy sets forth the requirements that govern research, development, and manufacturing in a regulated environment.

General Principles

Amgen functions with GxP operations must, as applicable:

• Establish GCP policies and procedures to ensure the generation of valid and reliable clinical data and results, safeguard the health of human study subjects, and comply with applicable laws and regulations.
• Establish GLP policies and procedures to ensure the generation of valid and reliable preclinical safety and other data and comply with applicable laws and regulations.
• Establish GMP policies and procedures to ensure appropriate controls are in place for the manufacturing, processing, packing and holding of drug products; that the safety, integrity, purity and quality of drug products are maintained; and to ensure compliance with applicable laws and regulations.
• Establish governance documents to ensure compliance with applicable laws and regulations related to other areas of compliance, such as “controlled substances” and the use of laboratory animals in research.