Product quality excellence is an unequivocal Merck standard.

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. We continuously strive to improve these standards in order to enhance procedures and ensure ongoing compliance with current Good Manufacturing Practices (cGMP).

All manufacturing facilities that Merck owns and operates, and any company from which we purchase formulated pharmaceuticals, active ingredients and sterile products, must comply with cGMP standards. These standards include requirements for verifying the sources of incoming materials, manufacturing, storage, handling and distribution of products.

Counterfeit products are a growing global problem and a serious threat to public health. We at Merck believe that maintaining the integrity of our supply chain is of paramount importance. Merck’s corporate global anti-counterfeiting program has three primary goals: securing the supply chain; deterring, rapidly detecting and responding to counterfeit activity; and raising public awareness about the risks posed by counterfeits. Learn more about Merck’s anti-counterfeit program.

Supplier Selection

We conduct due diligence and pre-contract audits of every potential new supplier of active pharmaceutical ingredients or formulated products and sterile products to determine its acceptability and compliance with cGMP. Merck reviews 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 Merck. Only if the supplier meets Merck’s 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 to manufacture a product for our use.

Audits and Inspections

We conduct periodic audits to further ensure that the supplier continues to meet cGMP. 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 of the product produced (e.g., whether it is a formulated pharmaceutical, active ingredient or sterile product) and how it is used by Merck
• Whether the formulated pharmaceutical, active ingredient or sterile product is produced using dedicated equipment and/or in a dedicated facility
• The technical complexity of the manufacturing process and operations (i.e., manufacturing difficulty) involved in producing the formulated pharmaceutical, active ingredient or sterile product

Quality tests are performed on all active pharmaceutical ingredients that Merck purchases 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 chemicals used in the manufacturing of our drug products is conducted in accordance with our specifications, which in many cases include the applicable Pharmacopeia standards (i.e., the United States Pharmacopeia (USP), the European Pharmacopeia (EUP), and the Japanese Pharmacopeia). The USP is the official standard for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. The standards are recognized and used in more than 130 countries.

Education and Training

We provide appropriate and ongoing training on quality and cGMP for our employees, to ensure they are prepared to perform their duties effectively. These systems not only ensure that all applicable employees are trained, but they also monitor the effectiveness of training.