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Quality Management

GMP Supplier Assessment Questionnaire
€ 87.00
€ 103.53
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
pdf download
GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and Excipients
Standard draft to adapt and expand
26 Pages
ISBN: 978-3-943267-84-6
Delivery: immediately after receipt of payment
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

Technical Requirements

This file is in PDF format!
Filesize: 781 KB

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
Cornelia Wawretschek
GxP Services, Berlin
Managing Contract Manufacturers and Testing Labs
Questionnaire for preparing GMP-inspections