Quality Certification
Customer issue
What distinguishes Merck from other suppliers? How do we benefit as Merck’s customers from the company’s unbroken tradition over the last centuries? Medicinal products as well as active substances and additives are subject to GMP regulations stipulated in ICH guidelines and implemented by national regulations in the US, Europe and Japan. Customers from the pharmaceutical industry are responsible for using raw materials that are produced according to the corresponding GMP regulations.
EMD’s solution
The quality promise has been part of our brand ever since the very beginning. In a letter to a customer in 1851, Emanuel Merck wrote: “I herewith guarantee the purity of my preparations and undertake to reimburse you for any damage that may arise through one of my preparations being impure.” Indeed, Merck’s brand design for many decades was based on his signature: “the confidence-inspiring signature of the pharmacist, expressing good quality and maximum purity.”
Today, integrated quality management systems form the basis for our quality philosophy. The successful audits conducted by our customers and by official agencies confirm that we adhere to a high level of quality standards.
Our Pharmacopoeia-products fulfil all c-GMP requirements for excipients. The specific requirements for the use of a product as an active ingredient are described in the ICH Q7A guidelines. All necessary measures have been taken for products where we got the notification that they are or will be registered as API with FDA or European authorities. DMF or CEP is or will be available.
Benefits for you
You are in good hands when you rely on Merck’s quality. We have been handling complexity in chemicals and pharmaceuticals for a long time – and you can rest assured that we have no intention of breaking with our tradition. Our tradition of care in quality matters is your guarantor.
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