With more than 700 questions and reference to GMP/GDP regulations and the EN ISO 13485, this chapter will be extremly beneficial when it comes to preparing GDP audits.
It is also the ideal tool for 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.
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 all in one.
The questionnaire is aimed at companies involved in the distribution chain of healthcare products, including:
The individual questions contain direct references to the following regulations: