Writing a GDP Training Programme: What does this mean in practice? Chapter 2 of the EU GDP Guidelines requires a written training programme. But what exactly does this mean and how can it be put into practice?
Regulatory Requirements
According to chapter 2.4 (Training) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use – 2013/C 343/01), the following applies:
Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme. The responsible person should also maintain their competence in GDP through regular training
In a similar way, chapter 3 (Personnel) of the EU GDP Guidelines for Active Substances (Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use – 2015/C 95/01) states the following:
3.3. Personnel should receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme.
Implementation
The overall staff training programme and schedule is often captured in a training matrix. This method is effective and can be tailored to roles and departments. Training frequency and results of competency tests can also be captured along with prompts for retraining. A simple Excel spreadsheet can be effective providing it is regularly maintained and reviewed. Training should be clearly split into stages tied with activities that may or may not be consequently performed by the individual.
Training processes can be split into the following four stages:
1. Training needs identification
2. Training guides developed (SOPs)
3. Training implementation and delivery
4. Training outcomes evaluation/ competence assessment Post-Covid measures do, of course, have to be considered, especially with regard to timings and schedules. The MHRA advised that although it is acceptable to forego annual GDP and SOP re-fresher training where there have been no significant changes to procedures and job-roles, it is still expected that where there are new starters/new job roles, a full and appropriate training programme would have been delivered.