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GMP LOGFILE Features

2017-05-24

LOGFILE No. 20/2017 – 85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

by Dr. Christine Oechslein

 

We have prepared for you page 2 of the document. Please click on the following link to read the excerpt.

LOGFILE-20_GMP-Questionnaire_page2.pdf

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Preparation for a first meeting

The GMP-Questionnaire consists of:

1 General Information
2 Site Master File

Parts 3 to 6 need only be completed if no Site Master File according with the EU GMP Guideline Part III exists:

3 Quality Management System
4 Personnel
5 Documentation
6 Quality Control

Author:

Dr. Christine Oechslein
GMP-Praxis, Bad Säckingen

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Literature recommendation
Quality Agreement
GMP Supplier Assessment Questionnaire
Managing Contract Manufacturers and Testing Labs