Quality Assurance and Quality Control activities should be performed effectively to ensure that products are designed, studied, manufactured, and tested to meet appropriate quality criteria. These activities should also be performed in accordance with applicable state, federal and international laws and regulations. Accurate and sufficient documentation should be provided for all appropriate processes and results.

Additionally, Amgen is subject to the oversight of regulatory bodies from the US federal government, from the states, and from other countries. Many of these regulators inspect Amgen to ensure compliance with laws governing the pharmaceutical industry. Amgen staff shall treat regulatory inspectors with respect and shall offer appropriate assistance to them during their inspections. Amgen will not tolerate any demonstrations of disrespect toward regulatory inspectors before, during, or after any inspections. Please refer to Amgen’s current Quality Policy for additional details regarding the policy and obligations of individuals subject to the policy.

Amgen’s Quality Policy applies to every Amgen staff member and temporary staff member, at all Amgen sites. Every individual who conducts business for or on behalf of Amgen, at every Amgen site worldwide, is required to follow all laws and Amgen policies applicable to him or her, and should exert due diligence in preventing and detecting violations of such laws and policies.