Our mission is to serve patients. This privilege comes with the responsibility to reliably deliver high-quality medicines.
Focus on Product Quality
Amgen is dedicated to delivering quality medicines on time, every time, utilizing a robust and reliable supply chain. Our Quality Management System (QMS) supports our compliance with quality standards through each stage of the product lifecycle, from research and development to manufacturing and distribution. Our QMS is built in accordance with over 150 country, regional, and international standards and regulations covering pharmaceuticals, medical devices, and combination products. These standards and regulations include:
- GxPs such as Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices, Good Distribution Practices, and Good Pharmacovigilance Practices.
- ICH Q7 (Good Manufacturing Practices for Active Pharmaceutical ingredients), and ICH Q10 (International Pharmaceutical Quality System Guidance).
- ISO 13485 (Good Manufacturing Practices for Medical Devices), as certified by TUV SUD and EU Notified Body.
Our Quality organization oversees our QMS. Amgen’s Quality Assurance professionals oversee processes in our manufacturing operations together with our Quality Control laboratories, which test product quality attributes. During product development, our Quality by Design approach uses the science of “human factors” to anticipate common user errors. This helps us design manufacturing processes and delivery devices that minimize the risk of errors. Each person who participates in manufacturing activities for, or on behalf of Amgen, at Amgen sites 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 concerns; to receive appropriate training; and to provide accurate and sufficient documentation of processes and results.
Monitoring and Auditing Quality Performance
We proactively monitor quality performance metrics to identify and focus our efforts on continuous improvement. Through a multi-layered governance program, we review action plans to address gaps in performance; evaluate quality events and departures from requirements; and review reports from customers, patients, and physicians, post-market surveillance results, and outcomes of regulatory inspections. Where appropriate, Amgen sites develop corrective and preventive action plans built from comprehensive root-cause determinations to help ensure we maintain high levels of compliance and quality. We report results, status, and progress through our QMS governance processes and escalate strategic QMS topics and critical product or process issues to Amgen leadership.
In addition, qualified Amgen auditors conduct assessments at risk-based intervals to identify and proactively address potential departures from expectations. We audit operations or activities that have a higher potential to impact product quality and/or patients more frequently.
We also audit the operations of our suppliers to help ensure the products they manufacture or services they provide meet Amgen’s and regulators’ expectations for quality.
Amgen has a robust training program for our employees and third parties within the scope of our QMS. Our training program is rigorously examined during internal and external audits.
Training for manufacturing activities begins during on-boarding when we train new hires on Good Manufacturing Practices and other requirements related to regulations, safety, and Our Code of Conduct and Corporate Compliance Policies (Code of Conduct). Relevant Amgen staff also complete regular refresher training and continuing education through our Learning Management System as needed. On average, full-time Amgen employees in Quality roles receive more than 100 hours of training per year across a broad range of topics. We assess the effectiveness of training through staff performance.
All Amgen staff receive annual training on adverse events and product complaint reporting. Amgen staff who learn of potential adverse events, product complaints, or other safety findings are required to report the information to our Global Patient Safety team in accordance with our corporate policies and Code of Conduct.
We also provide, track, and report training related to regulations and Amgen systems, processes, and procedures for employees of our third parties. Suppliers may be responsible for additional training. Under certain circumstances, we audit supplier training efforts.
Guarding against Counterfeit Medicines
Amgen takes the issue of counterfeit drugs very seriously and applies significant efforts to deter, detect, and disrupt criminal counterfeiting of our medicines, including by:
- Employing sophisticated technology to hamper the ability of counterfeiters to create packaging that resembles Amgen's packaging;
- In the United States, requiring wholesalers to buy only directly from Amgen, and auditing compliance with these purchasing practices; and
- Partnering with federal and state law enforcement agencies to investigate and prosecute those involved in product tampering and counterfeiting, facilitating the arrest and conviction of counterfeiters.
In addition, Amgen uses industry leading serialization and traceability technologies where required to advance the security of the supply chain and protect our products and patients. Amgen products have distinctive security features that allow us to confirm if a product has been legitimately produced following Amgen quality standards.
For more information, see our counterfeit drug statement.