13/14 December 2023
Since the EU Good Distribution Practice (GDP) Guide has been revised in March 2013 (an additional minor revision took place in November 2013) there is a lot of discussion about the interpretation of certain requirements. Among others, the training of personnel is a topic which received attention.
The GDP Guide states in Chapter 2 (2.4): "All personnel involved in wholesale distribution activities should be trained on the requirements of GDP. They should have the appropriate competence and experience prior to commencing their tasks. Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme."
Although it looks as the text is very general there are some important details which provide information. Those details are highlighted in the above text.
1) It is important to say that all personnel - and not only key personnel - need to receive GDP training if they are involved in distribution activities. This will also mean that for example also the truck driver and employees in the warehouse who handle medicinal products need GDP training. Companies are free to decide which training methods they use. In-house GDP Training Courses or GDP eLearning might be an option.
2) The training has to be performed "prior to commencing their tasks". This means that before a new employee can start any activities related to medicinal products training has to be performed. Inspectors might want to see the training records to check if the training was performed when the employee joined the company.
3) Initial and continuing training is required. Therefore there is not excuse to say that certain employees have already performed a certain task for years. Also here training records should state that ongoing training was performed
4) A training programme and a SOP which defines how the training programme will be managed is a key requirement. A comprehensive training programme for all employees in the GDP environment is a challenging task. A monitoring system is needed to identify when new or follow up training is needed.
Often discussions come up because of the word "should". However, the interpretation is clear. Every "should" in the GDP Guideline can only be understood as "must".
Chapter 2.4 also defines that certain tasks need special attention. Therefore employees need specific training if they are involved in those tasks. As examples the GDP Guide lists: hazardous products, radio active materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products. Moreover, the training "should include aspects of product identification and avoidance of falsified medicines entering the supply chain". This is certainly a requirement very few companies have already established.
Finally there is a requirement in Chapter 2.4 that training records should be kept and the effectiveness of training should be periodically assessed and documented. There is no statement about how the effectiveness can be checked. A documented exam/test is an obvious way to check the effectiveness, but there are also other options possible. In any case the effectiveness needs to be measured.