05.02.2019 | LOGFILE Feature 05/2019

Excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

4 min. reading time | by Cornelia Wawretschek

 

Personnel

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Premises and Equipment

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This is an excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire

 
Cornelia Wawretschek

Author

Cornelia Wawretschek
Pharmaceutical Technical Assistant
E-Mail: cornelia.wawretschek@gxp-services.de
 

GMP Supplier Assessment Questionnaire



The extent of supplier assessment depends on the significance of the supply. The more important the supply, the more information should be asked of the supplier to include it in the risk assessment.

The GMP-Supplier Questionnaire for APIs and Excipients consists of:

Part 1: Preliminary information on the supplier and the manufacturer

Parts 2 to 8: Detailed information on the manufacturer:

  • 2 Quality management system of the manufacturer
  • 3 Personnel
  • 4 Premises and Equipment
  • 5 Documentation
  • 6 Production
  • 7 Quality Control System
  • 8 Distribution, Complaints, Product Defects and Recalls

> More information and order
 
 

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