GDP Audit Questionnaire

Excerpt from the GMP Compliance Adviser

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of GDP audits

You 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:

• manufacturers of pharmaceutical and medical products
• distributors of APIs
• providers of logistics services
• wholesalers and agents

It can also be used when auditing service providers in this environment. The individual questions contain direct references to the following regulations:

• EU GDP Guidelines on medicinal products for human use
• EU GMP Guidelines
• WHO TRS No. 957 (2010), Annex 5
• DIN EN ISO 13485:2016

The questionnaire contains the following chapter from the GMP Compliance Adviser:

• Chapter 16.R: GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

The GDP Questionnaire is your perfect working tool!