GMP News No. 396
11 March 2004
What Does an Inspector Expect of
"Besides the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept."
How does the supervisory authority interpret these requirements? Within the framework of the CONCEPT HEIDELBERG event "Das GMP-gerechte Schulungssystem" (The GMP-compliant training system), Dr Neuhaus from the district government Cologne presented his interpretation of the GMP requirements.
In general employees should be trained according to their tasks, i.e. depth and frequency depend on the specific risk of the activity. There has to be a training programme that covers the points 'employees to be trained,' 'trainers,' 'contents,' 'evaluation of the training success' and 'documentation.' Training and further education should refer to all hierarchical levels; the higher the educational level, the fewer internal training efforts are necessary. Especially on a higher hierarchical level, external further education offers should be used systematically. Nevertheless, education does not replace specific training nor regular education courses.
In this training, apart from general GMP knowledge, the participants should be informed in particular about hygiene aspects, above all 'contamination risks,' 'the basics of hygienic behaviour' 'notifiable diseases' and company-specific requirements. Another focus should be on documentation; especially general documentation techniques as well as the use of SOPs are considered to be important. Another important point is the evaluation of the training success new employees should start to work independently only after having acquired sufficient knowledge and abilities.
The training frequency is oriented towards the degree of difficulty of the activity. However, training should take place at least once a year, critical subjects (e.g. aseptic manufacture) should even be trained more often. Another important point is the verification of the training success, which should be evaluated directly after the training, especially after re-training because of observed deficits, but also some time later (here 4-6 weeks were mentioned). The aim must be to determine that all employees have internalised the trained contents.
Furthermore any changes (e.g. of SOPs) have to be trained before they come into force. In this context, the employees often have difficulties in getting used to the new instructions.
Training schedules and programmes
The companies have to set up training schedules. Those responsible must know who is qualified - and also trained! - for which task. Some training courses have to be task-specific, others, site-specific. The training success can be evaluated by means of the qualification matrix, which can, in particular with larger groups, best be managed electronically.
Requirements to the trainer
It should be verified that the trainer has the necessary abilities. Besides the technical knowledge, this also includes didactical skills. Formal qualification in both fields is required (at least once a year).
It is problematical to judge an employee's individual performance, particularly under the industrial law in Germany. In order to implement the requirements of the EU GMP Guideline correctly, after an evaluation, it should be fixed in at least one written document that the employee has the necessary knowledge and skills and is able to perform his tasks independently and without permanent instruction or supervision.
In order to show how "training" can be misinterpreted, the following list gives some quoted examples from practice: