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.

Our quality strategy is focused on ensuring reliable, compliant supply to our customers, assuring that our products are there when people need them, and having an engaged and capable workforce to ensure and sustain future success.

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 requisite standards to 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 training.

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. These standards 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 anti-counterfeiting 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.

Supplier selection

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 to comply with our business requirements set forth in the contract, regardless of geography.

We conduct audits of every potential new supplier of active pharmaceutical ingredients or 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 in order to ensure the quality of the products the supplier hopes to provide to us.

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.

photo of an MSD scientist working in a lab

Audits and inspections

Our manufacturing facilities are inspected by international health authorities. In 2018, we had 100 regulatory inspections at our human health and animal health facilities. Ninety-seven (97) of the inspections concluded with satisfactory outcomes, and the outcome of one inspection is pending.

With respect to the remaining two inspections (both of which involved the same health authority), we have already addressed several of the observations. We are continuing to engage in activities to achieve successful resolution of the remaining observations.

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 a number of 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]).

Performance

QUALITY & PRODUCT SAFETY 2014 2015 2016 2017 2018
Number of product recalls in the United States1, 2 3 3 1 0 2
Annual percentage of units manufactured/sold and recalled during a given year (our global recall rate)1, 2 0.22% 0.07% 0.01% 0.01% 0.14%
1 Definition of Recall Classifications: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm#RecallClassifications.
2 Beginning in 2014, product recalls include data from our Animal Health business.