Excerpt: GMP Supplier Assessment Questionnaire

<span>Supplier Assessment Questionnaire &ndash; Personnel, Premises and Equipment GMP Supplier Assessment Questionnaire &ndash; Personnel, Premises and Equipment Excerpt from the GMP Series Download by Cornelia Wawretschek Personnel Source: This is an excerpt from the GMP Series...</span>

LOGFILE No. 05/2019 – GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

Excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire

4 minutes reading time

by Cornelia Wawretschek

Personnel

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Premises and Equipment
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LOGFILE-05-GMP-Supplier-Assessment-Questionnaire.pdf

Source:

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

Author:

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

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.

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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
Source: www.gmp-publishing.com