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GMP Guidelines

GMP Guidelines

All products at EMD, which are determined for human use, are treated under GMP aspects.

International standards control the quality and safety of drugs and the substances used in their manufacture.

These rules and regulations, generally known as cGMP Guidelines, are valid throughout the world and are expected to be ultimately codified into a global standard. In addition to established cGMP guidelines for the manufacture of active substances, discussions are currently underway on corresponding regulations for excipients. At EMD we participate actively in these policy forming discussions around the world.


Merck KGaA, Darmstadt, Germany

  • Audits its suppliers.
  • Operates a quality assurance system.
  • Produces numerous active ingredients and excipients according to cGMP.
  • Analyzes its products using a validated cGMP-conform system.
  • Effects transport using cGMP-tested forwarding companies.
  • Afrees to change-control-processes with its customers.
  • Compiles comprehensive product documentation.

Download our GMP statements:
GMP for Excipients

See also the references.

© Merck KGaA, Darmstadt, Germany, 2014

All references to Merck refer to Merck KGaA, Darmstadt, Germany.


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