Merck manufactures medicines and vaccines that are sold in more than 150 countries worldwide.

We verify incoming materials, manufacture, store, handle and distribute our products consistent with current Good Manufacturing Practices (cGMP) as well as other regulatory requirements – specifically those of the US Food and Drug Administration (FDA) or other applicable regulatory agencies, as applicable. Our quality and safety processes and procedures are broad in scope and include stringent quality and safety standards, compliance education and training, strict supplier selection criteria, and periodic audits and inspections.

We also support industry and regulatory efforts to develop and optimize quality and manufacturing standards worldwide, including work with the International Conference on Harmonization (ICH).

Quality and Safety Standards

Product quality excellence is a Merck standard about which we are unequivocal. We apply and adhere to a strict set of quality standards, and 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.

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 current Good Manufacturing Practice standards. These standards include meeting requirements for verifying incoming materials, manufacturing, storage, handling and distribution of products. Furthermore, all formulated products — and the active pharmaceutical ingredients they contain — that are marketed by Merck in the U.S. are produced in FDA-approved facilities, including facilities owned and operated by our suppliers.

Counterfeit products are a growing global program 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 worldwide anti-counterfeiting program has three primary goals: securing the supply chain; rapidly deterring, detecting and responding to counterfeit activity; and raising public awareness about the risks posed by counterfeits. For more information about Merck's anti-counterfeit program, please click here.

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 their acceptability and compliance with cGMPs. Merck reviews the systems that the potential supplier uses to purchase materials in order to ensure the quality of the products that it hopes to supply 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 with that supplier. These agreements include detailed provisions relating to the quality standards required by Merck to manufacture a product for our use.

Audits and Inspections

We conduct periodic audits to further ensure that the supplier continues 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 of the product (e.g. whether it is a formulated pharmaceutical, active ingredient or sterile product) produced and how it is used by Merck,
• Whether the formulated pharmaceutical, active ingredient or sterile product is used is produced using dedicated equipment and/or in a dedicated facility,
• The technical complexity of the manufacturing process and operations (i.e., manufacturing difficulty) 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 US. The standards are recognized and used in more than 130 countries.

Education and Training

We provide appropriate and ongoing training on quality and cGMPs 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.

 

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.