29.06.2018

GMP Compliance Adviser Update No. 5/2018

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:
 

GMP in Practice

24.P GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

GMP in Practice

Chapter 24 Storage and Transportation

24.P GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

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:

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

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

Interested in using the GMP Compliance Adviser?

>>> More information & order: GMP Compliance Adviser