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NEW Qualification Dossier, non-GMP

New product line - For Pharma Synthesis, non-GMP

EMD Millipore now offers you the opportunity to fully document the non-GMP raw materials used in API or other regulated organic 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 Millipore gives you information to qualify the material for appropriate use in your regulated production process. We now offer you raw materials, produced under non-GMP conditions, together with a comprehensive dossier for each product, that includes the specification, the test methods, information about the manufacturing process and impurities - everything you need to discuss your final product from start to finish.

Where do you need more information?

To fully document the raw materials used in regulated organic synthesis.

  Non-GMP GMP  
  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 Millipore'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, 2014

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


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EMD Millipore Chemicals

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