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Contract Manufacturer Agreement

No. 22/2012 - July 2012

Dear Colleagues,

an agreement between contractors is not optional, but it is a requirement by the EU and U.S. regulations. In our feature we help you to identify critical aspects in contractor agreements.

If you need further support, we can assist in detail with our appropriate GMP publications (see below).

Best regards,

Thomas Peither



Contract Manufacturer Agreement

Read about the minimum contents of an agreement to organize the subcontracting of manufacturing processes.

  • Documentation requirements
  • Quality System procedures
  • Manufacturing processes
  • Communication between

Click here to read the feature "Contract Manufacturer Agreement" by Max Lazar, U.S.


Contract Manufacture: Reasons, Duties, Audits

  • Why are steps in the processing chain passed to a contract manufacturer?
  • What documents must be handed over to the contract acceptor by the contract giver?
  • How often are audits carried out and what priorities are set?

Find answers to these questions in our e-book "Contract Manufacture", which is an excerpt from the GMP MANUAL.

PDF file | 56 Pages | ISBN 978-3-943267-21-1 | € 99 / US$ 149 plus tax if applicable

>>> Order now: Contract Manufacture - PDF Download


GMP News: Import of Active Substances

EC: Import of Active Substances

The European Commission has published the final template for the written confirmation for active substances exported to the European Union for medicinal products for human use. The new template has been published in Part III of EudraLex, Volume 4.

Read more ...


Regularly updated GMP regulations and interpretations

The GMP MANUAL includes the most important GMP regulations and interpretations in one source!

You will find it easy and efficient to find the appropriate information you are looking for. To stay current the GMP MANUAL is regularly updated.

Available as digital version or paper version.

>>> Click here to get more information: GMP MANUAL


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