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EMD Chemicals

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NEW Qualification Dossier, non-GMP

New product line - Pharma Synthesis non-GMP

EMD now offers you the opportunity to fully document the materials used in non-GMP synthesis.

Why do you need more information?

As the guarantor of your final product´s purity you may want to be able to retrace the origins and specifications of all materials involved in the production process. EMD gives you information to qualify the material for appropriate use in your pharmaceutical production process. We now offer you materials for pharmaceutical synthesis, non-GMP, that include dossiers about specification, manufacturing process, impurity information and everything you need to discuss your final product from start to finish.

Where do you need more information?
Fully document the materials used in non-GMP synthesis.  

  Non-GMP GMP  
EMD:/topic/images/pharma/psngmp_figure_text.jpg
  Products for pharma synthesis, non-GMP
  • Building blocks
  • Reagents
  • APIs
  • Excipients
  • Process chemicals
 emprove logo

What is your advantage?

  • Material accompanied by a Qualification Dossier
  • Opportunity to document all materials used for the final product from start to finish
  • Information available 24 hours a day on the internet
  • Support by EMD's well-established service

What do we provide?
Qualification Dossier for pharma synthesis, non-GMP

  • Specification
  • Monograph
  • Analysis and filling under the QM Management system ISO 9001
  • Manufacturing process
  • Impurity information
  • BSE/TSE statement
  • Change control on specification and manufacturer

© Merck KGaA, Darmstadt, Germany, 2012

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


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