Many of those who come into contact with the GMP environment for the first time are surprised by the high training requirements. Some of those firms that are already subject to GMP also wonder about questions like:
These and many more questions are attempted to be answered by a guideline of the World Health Organisation (WHO). With 144 pages, it is very comprehensive and is primarily directed at vaccines manufacturers. However, 50 of these 144 pages are shared out between 7 annexes with practical examples and an 8th with bibliographical references.
After very comprehensive quotations on the topic of training from a number of regulations, the guide explains training areas and methods. Among other things, the text deals with training requirements in connection with job changes and temporary workers, requirements in the field of GMP training that are known to be difficult to implement. On more than 25 pages, the development and implementation of a GMP training system is outlined. Here, two matrices are meant to give guidance: one on "instructional system designs", the other one on the identification of training contents and on the organisation of training courses. Simple lists of questions help e. g. to prepare the training room adequately, to develop a training event, but also to assess the instructor. For this purpose, the guide includes a rating table and three different blank feedback sheets. The possibilities for the general, but also for the individual assessment of the training success are also discussed in detail - together with the respective advantages and disadvantages. Administrative implementation possibilities of training programmes are explained in a practice-oriented way in the form of sample documents (training plan, training requirements on SOP training courses, several typical examples of certificates of attendance). A feedback questionnaire for WHO on this guide rounds off its descriptive part. Practical examples of training documentation and training SOPs and further sample documents can be found in annexes 1-7. Annex 8 completes the guide with a very comprehensive list of bibliographical references.
Conclusion: This WHO guideline on the topic of training is primarily directed at vaccines manufacturers who still have little contact to GMP. It enables the practice-oriented development and implementation of a GMP training system. Here, especially the big number of sample documents are helpful. However, it also includes many helpful pieces of information and practical tips for other firms subject to the GMP rules. Furthermore, it can be used to update one's own training system to the "state of the art".
The WHO guide can be found here.
You will get a basic overview of the GMP requirements on manufacture at the ECA event "GMP for Beginners" in Prague on 24-25 February. The programme can be found here.
On behalf of the European Compliance Academy (ECA)