Written 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 training programme 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 four stages:

• 1. Training needs identification
• 2. Training guides developed (SOPs)
• 3. Training implementation
• 4. Training outcomes evaluation

More details about the four stages can be found in the PQG/ECA Interpretation Guide on GDP (

Guidance on the interpretation and implementation of European Good Distribution Practice). 

This document has been published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group of the Chartered Quality Institute.

This document and its chapters are built around the format and text of the EU GDP Guidelines, providing a sound basis for the implementation and maintenance of a GDP quality system with clear responsibilities and processes and the application of risk management principles.

The document is accessible free of charge in the members' area of the European GDP Association's website.

If you are interested in the publications, but you are not a member yet, you can apply for membership using the application form. Membership is available at no cost. Once you are signed in, the documents will be available for you.