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Product Quality Standards
Scientist wearing protective gear

(Photo: Tom Maday ©2005)


Merck manufactures products that are sold in more than 150 countries worldwide. Our first concern with any product is patient safety. Merck is committed to quality in the manufacturing, packaging and testing of our products to meet or exceed regulatory authority requirements and expectations for current Good Manufacturing Practices (cGMPs). We work to ensure continuous improvements in quality and compliance by auditing our quality practices and establishing goals, programs and procedures that ensure product quality and cGMP performance. Divisional and corporate management regularly review progress against these goals. We also provide appropriate and ongoing education and training programs on quality and cGMPs for our employees to ensure they are prepared to perform their duties effectively.

Merck maintains global standards of quality. We are involved in and support external industry and regulatory efforts to further develop and optimize quality standards, including work with the International Conference on Harmonization, a worldwide effort to improve and standardize product quality standards and make consistent manufacturing standards worldwide.

Anticounterfeiting

Availability of counterfeit or adulterated pharmaceutical medicines and vaccines is a growing global problem that can compromise patient health and safety. For this reason, we are actively engaged worldwide in efforts to prevent the distribution of counterfeit medicines and vaccines.

In the United States, for example, Merck has implemented new terms and conditions of sale for our medicines that are designed to reduce the potential for counterfeit pharmaceuticals entering the supply chain by requiring that customers purchase Merck products directly from Merck or a Merck authorized distributor. In addition, we are working with industry associations to determine how best to use electronic authentication technologies, where appropriate, and to secure the drug supply against counterfeiting threats.

In the European Union, Merck is working to increase proactive cooperation with law enforcement agencies -notably Customs authorities - to act against the increasing importation into the EU of counterfeit medicines which are being widely advertised on and made available via the internet. Merck also has worked with the European Federation of Pharmaceutical Industries and Associations (EFPIA) on publishing the first joint industry statement deploring counterfeiting and the associated dangers and setting out the industry position in support of public safety, a secure supply chain and retail market and enhanced regulatory and judicial action against counterfeiters.

To learn more about Merck's commitment to science, innovation and quality, click on the links below:

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