Quality & Safety Standards
In everything we do—from research and development to the manufacturing and distribution of our medicines, vaccines and other products—safety, quality and efficacy are our primary considerations.
We will maintain strict quality standards and effective supply chain management to ensure the safety of our products, no matter where they are manufactured
Our quality strategy is focused on ensuring that we maintain a reliable, compliant supply of products to our customers and that we have an engaged and capable workforce ready to deliver and sustain success.
We operate in a highly complex and ever-changing regulatory landscape driven by many different factors, including novel scientific discoveries, technological advancements, natural disasters, global pandemics and cybersecurity events. However, we strive to ensure the overall quality and continuous supply of products by aiming for two simple objectives: zero market actions and zero unsatisfactory inspection outcomes.
Patient safety is at the forefront of what we do. We are using and exploring new technological advancements such as integrated IT tools, artificial intelligence (AI) and streamlined digital platforms to further enhance how we manufacture high-quality products.
We apply and adhere to a strict set of quality standards, and we have policies and procedures in place to identify, measure, control and sustain product-quality excellence.
Our Global Quality Compliance organization is responsible for establishing the standards that ensure that all of our company’s products are manufactured, tested, released and distributed in full compliance with regulatory requirements.
We continuously strive to improve these standards in order to enhance procedures and ensure ongoing compliance with Current Good Manufacturing Practices (CGMPs).
We provide appropriate and ongoing training on CGMPs for our employees, so they are prepared to perform their duties effectively. Our system not only ensures that all applicable employees are trained, but also monitors the effectiveness of the training provided.
All manufacturing facilities that we own and operate, and any company from which we purchase formulated pharmaceuticals, active ingredients or sterile products, must comply with CGMPs. CGMPs include requirements for incoming materials and the manufacturing, storage, handling and distribution of products.
Counterfeit products are a growing global problem and a serious threat to public health. We believe that maintaining the integrity of our supply chain is of paramount importance. Our corporate global product integrity operations program has three primary goals: securing the supply chain; deterring, detecting and responding to suspected and/or confirmed counterfeit activity; and raising public awareness of the risks posed by counterfeits.
We maintain strict quality standards no matter where our products are manufactured. Once we have decided to engage an external manufacturer, that manufacturer is required, by contract, to comply with our business requirements, regardless of where the manufacturer is located.
We conduct audits of every potential new supplier of active pharmaceutical ingredients, formulated products and sterile products, to determine its acceptability and compliance with CGMPs. We review the systems that the potential supplier uses to purchase materials to ensure the quality of the products the supplier intends to provide to us for our further use.
Only if a supplier meets our stringent criteria, which include a review of the company’s regulatory inspection and outcome history, will we then negotiate a commercial agreement. These agreements include detailed provisions relating to the quality standards we require suppliers to uphold in order for them to manufacture a product for our use.
Audits and inspections
Our manufacturing facilities are inspected by international health authorities. In 2019, we had 83 regulatory inspections at our human health and animal health facilities. All the inspections concluded with satisfactory outcomes.
We conduct periodic audits to further ensure that suppliers continue to meet CGMPs. Through such audits we evaluate the continued acceptability of the facility from a quality assurance and regulatory compliance perspective.
The frequency of quality auditing depends on several factors, including:
- The nature and complexity of the product being manufactured (e.g., whether it is a formulated pharmaceutical, active ingredient or sterile product) and how it is used by our company
- The compliance history of the supplier and previous audit results
Quality tests are performed on all drug substances that we manufacture or purchase as part of our overall supplier-qualification process, and further tests are performed during subsequent stages of manufacturing. Quality tests are performed on all formulated products before we release them to the marketplace.
Testing of raw materials or excipients used in the manufacturing of our products is conducted in accordance with our specifications, which in many cases include the applicable pharmacopeia standards (e.g., the United States Pharmacopeia [USP], the European Pharmacopeia [EUP] and the Japanese Pharmacopeia [JP]).
Working in partnership with others
We have a strong commitment to working with our industry peers and regulatory agencies through formal partnerships within prominent not-for-profit associations. Subject matter experts across the quality organization use their decades of knowledge and experience to lead technical committees, collaborate in scientific working groups and partner with global colleagues on regulatory initiatives.
Through these types of partnerships, which operate within legally compliant frameworks, we promote the sharing of best practices and cutting-edge innovation while ensuring the quality of our products. Additionally, many of our Quality leaders also serve in prominent positions (e.g., on boards of directors) within industry associations, lending their invaluable expertise and guiding the future trajectory of the industry.
|Quality and product safety||2015||2016||2017||2018||2019|
|Number of product recalls in the United States1||3||1||0||2||1|
|Percentage of sold units recalled during a given year (recall rate globally)1||0.07%||0.01%||0.01%||0.14%||0.01%|
|1Definition of Recall Classifications: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm#RecallClassifications.|