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QA requirements for suppliers of pharmaceutical raw materials

Dear Sirs

As a pharmaceuticals manufacturer, our company, Bayer Weimar GmbH und Co. KG at Weimar (BWG), is bound by stringent statutory regulations and must obtain quality materials only from internally assessed and approved suppliers who also meet basic QA requirements.

We would therefore be grateful if you would provide the following information to ensure appropriate supplier management in accordance with EC GMP guidelines and AMWHV where applicable:

Details of the material supplied:

  • for original manufacturers: certificate of analysis with the date of manufacture and expiry date (for each delivery)
  • for merchants: certificate of analysis from the manufacturer (copy) for the material supplied and (where applicable) an additional certificate of analysis from your company (for each delivery)
  • current safety data sheet in accordance with ISO 11014-1 or TRGS 220 (where applicable and not yet provided; one-off and on amendment)

Information subject to approval for general quality assurance:

(Intended amendments may only be implemented after we have examined and approved them)

  • information on an intended change of manufacturing site
  • information on intended quality-related amendments in the manufacturing technology
  • information on intended quality-related amendments to test procedures during manufacture and/or in the final control procedures
  • information on an intended change of raw materials that will have a major impact on material quality
  • information on any intended sub-contracting of manufacturing and/or assay work

Information on quality-related deviations

  • Information on deviations from the correct manufacturing and/or assay process that may impact on the quality of the material supplied

Would you please send the relevant documents and information to (BWG) (by post, e-mail or fax: (03643) 433 1329).

For merchants handling pharmaceutical raw materials:

We also require the above information from merchants who do not themselves manufacture the materials supplied but purchase them from an original manufacturer and sell them on. Merchants should request the information from the relevant manufacturer and forward it to BWG (EC GMP guidelines / part II / section 17).

The QA requirements set out in this document are in addition to our general terms and conditions of purchase and are effective immediately.

Thank you for your help in this matter.

 

Yours faithfully

Bayer Weimar GmbH und Co. KG

Head of Logistics

Head of Purchasing


© Bayer Weimar GmbH und Co. KG