14/15 December 2021
In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic.
Below you will find the first set of questions which have been answered by the speakers' team. Further Q&As will be published step by step within next weeks. All answers reflect the opinion of the speakers based on their experience.
Question 1.1: What is seen as regular training in GDP; once per two years or a shorter timeframe?
Answer: Regulators expect annual GDP refreshed training for staff. It is up to the company to define how this is achieved and be able to justify their approach. Staff should demonstrate competence for the tasks they perform and the responsibilities they hold. The training frequencies could for example be determined by the complexity of the task and the experience of the staff.
Question 1.2: How should I review the training effectiveness? Qualitatively or quantitatively? Or by any other means?
Answer: Staff should demonstrate competence for the task performed and for the responsibilities they hold. Review will therefore depend on the subject of the training, all of these are relevant, some training needs formal assessment, others may require observing the trainee to ensure he is capable of performing the task. This should be defined in your training programme, records should be kept.
Question 1.3: There are different types of wholesalers; for wholesalers with a warehouse it is clear that more training is needed per year. However, a commercial affiliate or trading entity only buys and sells the goods and outsources the warehouse and transport.
Answer: Training should be relevant to the nature of the business, so for a commercial company you need to decide what activities your company is performing, then decide on the nature of training. For example, key focus areas for training would be customer qualification, supplier verification, management of outsourced partners and associated activities. The RP would still retain responsibility for decisions on stock disposition in the event of a complaint, return, recall, suspected falsified medicine etc. as well as documenting physical and financial product flows, generating quality and risk management reports. Finance personnel need to be trained in supporting product recall activities and stock reconciliation. IT systems need to be assessed to demonstrate compliance to GDP and the requirements of data integrity maintained, e.g. effective management of master data.
Question 1.4: The Responsible Person (RP) should ensure a training programme is in place and staff is trained. Can the training tasks be designated to the human resource department or should this be a part of the QA department?
Answer: We would expect the training is developed and approved by the RP/QA department, in some companies the HR manages and organizes the training sessions.
Question 1.5: What would be the preferred content of qualification of the GDP trainer?
Answer: Qualified and experienced in GDP.
Question 1.6: What industry-standard training courses/certification are there for RPs that you can recommend?
Answer: ECA runs courses.
Question 1.7: Activities to third parties - Are 3 to 5 GDP-related training courses per year then still needed?
Answer: Training should be relevant to the nature of the business, so for a commercial company you need to decide what activities your company is performing, then decide on the nature of training. Regardless of the size or activities of the wholesaler, all personnel need to be trained on the activities being conducted by them including retraining on any updated procedures and annual GDP training. This means that personnel need to be trained on the activities prior to conducting those activities, and so this would not likely be complied with by conducting training at a set frequency as per the question.
Question 1.8: Are there requirements on training records for specific tasks (handling of deviations, change requests, complaints, release of product etc)?
Answer: Personnel must be trained in the activities being performed by them. Furthermore, personnel should be trained in GDP activities which they may be exposed to - for example: complaints, recalls, falsified medicinal products.
Question 1.9: What are some examples of how to conduct the periodical assessment of the effectiveness of training?
Answer: Observation of the person conducting the task, discussion of task and related activities with the person, review of previous deviations and complaints, retraining.
Question 1.10: Regarding training effectiveness: is a knowledge check mandatory?
Answer: Individual training event knowledge checks are not mandatory but is considered best practice. This is also dependent on the type of training being provided. The GDPs do require that the effectiveness of training is routinely evaluated and documented.
Question 1.11: Is it enough with a training plan for the QA team or does it need to be per employee?
Answer: All employees should have a training plan as it is best practice regardless of whether they are performing GDP activities or not. Furthermore, GDP activities are not usually restricted to the QA team - with, for example operations, sales, warehousing etc being involved as well.