Quality
Our mission is to serve patients, which is a privilege. This privilege comes with the responsibility to deliver quality medicines. Amgen is dedicated to delivering these quality medicines on time, every time, utilizing a robust and reliable supply chain.
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.
Ensuring Product Quality
Quality at Amgen is an integral part of our culture. As a company, we maintain our commitment to quality and to the patients we serve, by focusing on proactively ensuring product quality through a variety of means:
- Our Quality Management System is robust and sophisticated, yet simple. It enables us to maintain quality during every step of the development of the product and its manufacturing process. Oversight of the Quality Management System is led by the Quality Unit, which is independent of the manufacturing organization.
- Our rigorous audit program ensures that the Quality Management System is implemented correctly, closely monitored and followed across the Amgen supply network.
- Amgen’s Quality Assurance professionals oversee processes on the manufacturing floor, in conjunction with an extensive network of Quality Control laboratories that test product quality attributes.
- A “Quality by Design” approach integrates quality into our products and processes during development. This approach includes applying the science of “human factors” to anticipate common user errors and then designing the manufacturing process and delivery devices in a way that minimizes the risk of such errors.
Employing Well-Trained Staff
Amgen staff are trained to understand job requirements and applicable 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 cause of concern; to receive appropriate training; and to provide accurate and sufficient documentation of processes and results.
- Our staff members work actively on various industry committees to contribute to new regulations.
- We require the partners we work with to be compliant as well.
Understanding and Responding to Evolving Global Regulatory Environment
Amgen analyzes global information to identify emerging issues and significant events that could potentially affect our products or facilities and employs technology and monitoring to protect against counterfeiting and diversion in order to effectively respond in ways that will protect the supply of quality products to patients.
Addressing Concerns
Amgen takes potential quality and safety concerns seriously. Questions from customers, patients, physicians and the general public are investigated in accordance with our Quality Management System so that corrective actions can be implemented where appropriate across Amgen’s global network of facilities and suppliers.
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.