QA requirements for suppliers of pharmaceutical packaging 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:

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).

The above QA requirements 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