As part of our mission to serve patients, Amgen is dedicated to delivering medicines of consistent high quality. Ensuring quality is one of our core values. The Quality function at Amgen, along with all of Operations, is guided by this value and committed to safeguarding patients, Amgen staff and our communities.

Quality at Amgen is an integral part of our culture. As a company, we maintain our commitment to quality and to patients, by focusing on proactively ensuring product safety and efficacy through a variety of means:

• We ensure quality every step of the way.
  
  We use quality assurance to control our products and processes.
  
  This includes a Quality Management System approach which enables us to maintain compliance with regulations and continuously improve our processes.
  
  It also includes Quality by Design, a concept which means we proactively build quality into our products as well as our development and manufacturing processes.
  
  In addition, we make it a top priority to ensure the quality of the raw materials we use to make our products and the security of the supply chain that brings the products to doctors and patients.
  
• We ensure all staff know what to do and follow appropriate regulations.
  
  Every person who participates in manufacturing activities for or on behalf of Amgen, at every Amgen site worldwide, is required to adhere to all applicable laws, regulations, policies and procedures; to exert due diligence in preventing and detecting violations and to promptly report any causes of concern; to receive appropriate training; and to provide accurate and sufficient documentation of processes and results.

• We work proactively to understand and respond to the evolving global regulatory environment.
  
  Our staff members work actively on various industry committees to contribute to new regulations. We ensure the partners we work with are compliant as well.

• We protect our product brands against counterfeiting and diversion.
• We manage and understand risks to ensure we’re able to supply products to patients.

At Amgen, ensuring quality is not just our job, it’s our responsibility to patients which we take very seriously and work hard to ensure. In the end, it’s about making sure the medicines we deliver are safe and effective for patients.