New Q&As on Chapter 4 and 5 of the EU-GDP Guidelines
Recommendation
6/7 November 2024
Temperature controlled Transports of Medicinal Products
On the GDP Association Website a section was set up a while ago dealing with frequently asked questions (FAQs). Now a set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).
For example, the following questions are discussed:
- Who authors documents? Who needs to approve them?
- In which language should documents be written?
- Is it allowed to print procedures from an electronic system?
- How can I check if a supplier has an appropriate legal authorisation?
- Besides temperature, are there other environmental factors which might harm medicinal products?
- Why do I need to qualify customers?
Answers to these and other questions are provided in the new FAQs on GDP.
Related GMP News
10.10.2024SwissGMDP Database now available
10.10.2024New MHRA Guidance for Wholesalers and Manufacturers
10.10.2024Abbreviations used in the GDP Environment
10.09.2024Checklist for Implementation of GDP Principles - Part 10: Specific Provisions for Brokers
10.09.2024Swissmedic updates Responsible Person Requirements
10.09.2024PDA publishes Technical Report on Last Mile Distribution