Quality Assurance

Biotechnology supply

We check. Then we check again.

At Amgen, we are focused on a common goal: to make sure high-quality medicines get to every Amgen patient, every time. We achieve this in part by capitalizing on our 100-country-strong infrastructure, in which all facilities follow the same processes to:1

  • Produce high-quality medicine
  • Deliver a reliable supply of medicine

Focused on ensuring quality

Protecting patients is paramount. We invest heavily in risk mitigation on all levels to serve our patients and care providers, so we can quickly correct course should any issues arise. From the lab to the bioreactor to final delivery, biosimilars are typically subjected to numerous quality checks to ensure their similarity to the respective reference products.2

Amgen employs two primary types of systems to ensure quality:2

  • Quality Management Systems that help ensure adherence to normal variability standards
  • Quality by Design Principles, a systematic approach to development that begins with redefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management that are part of important processes developed to ensure high-quality and compliant medicines

Not only that, we take complete responsibility for our medicines after they leave our facilities, with effective monitoring standards in place to help ensure:

  • Rapid traceability
  • Monitoring of safety events
  • Accurate identification of specific biosimilars and biologics used by individual patients

An outstanding record of reliable supply

At Amgen, we make medicines for serious illnesses and chronic conditions that may deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

At Amgen, we make medicines for serious illnesses and chronic conditions that may deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

Amgen implements product security programs to help
ensure a reliable supply of its medicines to patients

To maintain reliability, we depend on our manufacturing and distribution infrastructure to help ensure a consistent supply of high-quality biosimilars across Canada.3,4 We implement product security programs that eliminate shortages and help ensure quality.5

It is because of measures like these that we have one of the best records for lack of drug shortages in the pharmaceutical industry in 2017.5

References: 1. Amgen Fact Sheet. Accessed August 21, 2018. Available at: https://www.amgen.com/~/media /amgen/full/www-amgen-com/downloads/fact-sheets/fact_sheet_amgen.ashx. 2. ICH. ICH Harmonised tripartite guideline. Pharmaceutical Development Q8R (R2). 2009. Accessed May 24, 2018. Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/ich/qual/q8r2-step4etape-eng.pdf. 3. Amgen Corporate Brochure: The Amgen Difference. Accessed August 21, 2018. Available at: https://www.theamgendifference.com/assets /doc/theamgendifference.pdf. 4. Amgen Corporate Brochure: Unlocking the Potential of Biology for Patients. Accessed August 21, 2018. Available at: https://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/amgen_corporate_brochure.ashx. 5. Data on file, Amgen; 2018.

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