28/29 October 2020
Chapter 2 Personnel of the EU GMP Guide lays down that employees must be instructed on GMP regularly. The EU GMP Guide states that "continuing training should also be given, and its practical effectiveness should be periodically assessed." Therefore, many companies perform annually GMP trainings to comply with this instruction and document it.
Yet, the main challenge lies in the concrete implementation. On the one hand, efficiency is required as there are generally a large number of people involved in GMP-related activities. On the other hand, the objective of the GMP instruction is to provide GMP know-how to the employees who have to use GMP for their daily work. Usually, department-specific training courses are organised and documented. Some of these training courses are carried out by a technical supervisor or a training representative who has the necessary professional and didactical qualification. External GMP trainers are also frequently tasked with that. Concept Heidelberg - on behalf of the ECA Foundation - performs in-house training courses for more than 100 pharmaceutical and API companies per year.
In case employees cannot take part in a training course on the planned date they have to be trained within a reasonable period. Organising an additional training session for 1 or 2 employees is, in turn, time-consuming and expensive. More and more companies thus use a combination of self-organised training, external GMP training and GMP eLearning courses. Purchasing, setting up and using e-learning modules used to be complicated. That's not the case anymore. Small companies as well as individuals don't need any licence. On the internet they can simply book a training course "on demand", participate and then receive a recognised GMP certificate of participation.
Larger companies tend to buy a company licence to get training courses at reduced costs. The following rule applies: the more employees must be trained annually, the cheapest the prices are per participant. More than 300 pharmaceutical companies in around 30 countries use such an e-learning system - like that developed by the company MediaVision in Holland. Today, there are 9 GMP courses available in 11 languages - among them: mandarin Chinese. Yearly, more than 2,000 employees are trained with the system. The training courses offer a range of advantages: training is available any time and anywhere. No need for software, only for an internet connection. Employees who don't have their computers can just use that of their superiors or one in a training room. A special GMP refresher training course has been developed to remind of the GMP implementation. The contents of this training course are compacted in about 3.5 hours training videos taken directly in the production facilities of different pharmaceutical companies. Companies with a framework contract have the possibilities to individually set different training contents per employee. For example, you can select a 30 minute long video on special behaviours regarding change control or validation, or cleaning. These short videos are often much more effective than training extensive contents at once. For example, an employee who has been trained on GMP-compliant documentation can plan another training course on maintenance 6 months after. This is not only a matter of time but efficacy for the employee. Experience has shown that the knowledge learned remains longer than when different topics are trained at once.
Here a few words about the contents of a GMP training course: two of the biggest challenges may be motivating the employees to regularly take a course and teaching in an attractive and modern way. Indeed, it is important to use more than just pages and pages of text. GMP e-learning courses should include almost no text information. The teaching contents are presented in videos which show concrete situations, i.e. filling lines in a clean room. In the videos you can see for example what causes a cross contamination. This is much more demonstrative than reading a text listing the possible causes. To watch some sequences please see the demos.
Generating a certificate after successful training may also be time-consuming and expensive. At the end of a GMP eLearning training course, you can pass a test and - if successful - receive a certificate. Of course, the GMP eLearning system not only has advantages. One should find a balanced mix of classroom training and e-learning. Moreover, from time to time one should invite a new GMP trainer for internal training. On the long term, the quality of successful training can only be enhanced when alternating GMP trainers and media.