The implementation of the new EU Good Distribution Practice Guideline is a challenging task for all companies involved in the handling of pharmaceuticals. In this respect, the EU Commission issued a very useful document to provide answers to a number of questions relating to GDP implementation. Some examples which somehow relate to transportation companies are listed below:
Chapter 2 – Personnel
What is the definition of “competent”?
Answer: Having the necessary experience and/or training to adequately perform the job.
Is it possible to employ staff starting their professional career?`
Answer: Yes, if you properly training them before assigning them to their tasks.
What is meant by “periodically assessed”?
Answer: Assessed at regular intervals. The timing of intervals is left flexible, without prejudice to national legislation.
Chapter 3 – Premises and Equipment
What are appropriate settings for the alarm levels?
Answer: Alarm settings should be chosen as to guarantee a timely alert of personnel when there are excursions from predefined storage conditions.
Chapter 6 – Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
How should the customer demonstrate that the medicinal products have been transported, stored and handled in compliance with specific storage requirements?
Answer: The customer needs to provide papers showing that the medicinal products have been transported, stored and handled in compliance with their specific storage requirements.
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.
Are transportation companies required to hold a wholesale distribution authoristaion and comply with GDP?
Answer: Transport companies do not need to hold a wholesale distribution authorisation to transport medicinal products. However, they should follow the parts of the GDP guideline relevant to their activities, amongst others Chapter 9.
A copy of the EU Commission document with all the questions and answers can be found in the following link: GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE ‐ QUESTIONS AND ANSWERS ‐ VERSION 1.0