14-16 April 2021
The international GMP regulations, e.g. the EU GMP Guidelines and the FDA cGMP 21cfr 210/211, require that only trained personnel may be employed in production, quality control and all other areas involving GMP tasks. The GMP/GDP regulations, e.g. the EU GMP Guide, also contain these requirements. In addition to a basic qualification in GMP/GDP, this knowledge must be regularly updated ("refresher training"). Furthermore, training must take place whenever changes or innovations occur in the working environment. The documented evidence of training planning and implementation is monitored by the regulatory authority within the framework of GMP/GDP inspections.
In the course of a survey in the GMP/GDP environment, about 200 questionnaires have been completed. The aim of the survey was to record the current status of the implementation of GMP/GDP training measures in the pharmaceutical industry. Approximately 50% of the participants in the survey come from medium-sized companies, about 30% from international groups and about 20% from smaller companies.
Around 71% of the companies therefore train GMP/GDP once a year. Another 14% train two or even three times a year. Only 5% of the companies train every two years. This indicates that the vast majority of companies are very systematic. However, it can also be seen that about 10% of the companies have not defined fixed dates for GMP/GDP training. The survey does not provide any information on how these companies ensure the necessary training measures.
Many GMP/GDP training courses are conducted by the companies themselves. Additionally, companies use external training courses to cover their training needs. The main reasons given for using external training are the exchange with experts in the same field from other companies and getting to know other ways of implementation. The quality of training courses in the companies are rated as follows:
Only 10% of the respondents are unsatisfied with the internal training. However, only about 40% of those surveyed rated the training courses as good.
The aim of the survey was also to determine whether the GMP/GDP training is considered sufficient with regard to the activity carried out. This resulted in a unexpectedly clear statement:
According to the survey, over 40% of respondents would like to improve measures to acquire the necessary knowledge in the GMP/GDP environment. This result was not to be expected in this form and makes it clear that pharmaceutical companies should identify training needs and the training measures (internal or external) derived from them more closely.