Customer Audits
Customer issue
As a pharmaceutical manufacturer, you need to know whether Merck’s production of Active Pharmaceutical Ingredients (API) or
excipients you buy meets the GMP prerequisites, the strict requirements set by regulatory authorities. This can be due to
requirements from your purchasing department or quality control or the need to comply with regulatory authorities’ demands.
Perhaps you are from Germany; perhaps you are among the 90% of auditing customers that come from other parts of the world.
EMD’s solution
Selected steady Merck customers can take an opportunity to visit Merck’s production site in Darmstadt to ensure that the quality of the production processes meets their standards. About 80 did so in 2004.
The specialized team from Regulatory Affairs plans, prepares, executes and follows up on quality audits. They are planned to follow a specific product flow, starting from goods entry all the way to picking and packing. A program is put together taking the customer’s specific interests into account. The relevant systems are of course audited at the same time. In just one day, it is possible to closely examine flows of different products or product groups.
Issues that arise are discussed over the course of the day, but the final word on improvement potential is the audit report Merck receives from the customer after four weeks, in which corrective actions are suggested and a timeframe is defined.
Benefits for you
We at Merck invest time and care to maintain close trust-based relationships with our customers. Merck also benefits from the audit results, both in learning the uses of our products in specific customer applications and through the improvements made on the basis of suggested corrective actions. Merck’s customers often praise the openness with which their questions are dealt with and the commitment to continuous improvement this demonstrates.
Merck also conducts audits of the joint audit group as part of the German Association of Research-Based Pharmaceutical Companies (VfA), whose audit reports are recognized by a great number of well-known manufacturers.
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