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![]( "Buchcover ISBN 9783958071087")
- manufacturers of pharmaceutical and medical products,
- distributors of APIs,
- providers of logistics services,
- wholesalers and agents.
GDP Audit Questionnaire
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices
von Christine Oechslein, Max Lazar und Bernhard GotterYou need to prepare for an audit or an inspection to come, a self-inspection or your own GDP audit of suppliers and subcontractors? The GDP Audit Questionnaire facilitates an efficient preparation, helps you save a lot of valuable time and ensures that the requirements are fully met!
This questionnaire is a practice-oriented tool for preparing and implementing self-inspections with an emphasis on GDP (Good Distribution Practice). Compliance with GDP requirements during the product life cycle of medicinal products for human use, their active substances, and medical devices can be monitored, checked and directly documented using a list of questions.
The questionnaire is aimed at companies involved in the distribution chain of healthcare products, including:
It can also be used when auditing service providers in this environment. The individual questions contain direct references to the following regulations:
These are the main topics of the questionnaire:
The GMP Audit Questionnaire works great for both sides - the auditor and the inspected company. It facilitates an efficient preparation for - an audit or an inspection to come - self-inspections - your own GMP audit of suppliers and subcontractors.
This questionnaire is a practice-oriented tool for preparing and implementing self-inspections with an emphasis on GDP (Good Distribution Practice). Compliance with GDP requirements during the product life cycle of medicinal products for human use, their active substances, and medical devices can be monitored, checked and directly documented using a list of questions.
The questionnaire is aimed at companies involved in the distribution chain of healthcare products, including:
It can also be used when auditing service providers in this environment. The individual questions contain direct references to the following regulations:
These are the main topics of the questionnaire:
The GMP Audit Questionnaire works great for both sides - the auditor and the inspected company. It facilitates an efficient preparation for - an audit or an inspection to come - self-inspections - your own GMP audit of suppliers and subcontractors.