13/14 December 2022
The implementation of the new EU Good Distribution Practice Guideline is a challenging task for pharmaceutical companies, wholesalers, storage facilities and transportation companies. However, a very helpful document is available from the EU Commission which provides answers to a number of questions for GDP implementation. Some examples are listed below:
Chapter 3 Premises and Equipment: What is meant by initial temperature mapping?
Answer: An initial temperature mapping is an exercise in which temperature sensors are placed on the points identified as"most critical" through a risk analysis. (e.g. at different heights, near a sunny window, next to the doors, etc.). Once placed, a measurement is taken over a period of time and with the results obtained, the temperature sensors will be placed where greater fluctuation occurred. The mapping should be performed in different seasons where highest and lowest temperatures are reached.
Chapter 5 Operations: How can wholesalers prove that the medicines they receive are released for sale?
Answer: The batches of medicinal products which have undergone the controls referred to in Art. 51 of Directive 2001/ 83/EC in a Member State are exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person. In other words, the batch arriving from another Member State needs to be accompanied by evidence that the manufacturer’s qualified person has certified the finished product batch for the target Member State. The technical means by which this evidence is provided has been left to the discretion of the companies: a physical control report or an equivalent system of proof of release.
Chapter 9 Transportation: Can we deviate from storage conditions if the manufacturer agrees to the transportation of the product within a certain temperature range (2 - 25 C.) for a limited time frame of 6 hours?
Answer: No. Storage temperature limits as described by the manufacturer or on the outer packaging need to be respected for each stage of transport during the whole transport chain.
Please find all Q&As in the document: GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE - QUESTIONS AND ANSWERS - VERSION 1.0