Training
Inspectors must have a good working knowledge of the national legislation and the GMP guidelines that manufacturers are expected to comply with. They must also know the range of sanctions they can use if necessary.
Before carrying out inspections on their own, new inspectors should first accompany a more experienced colleague as an observer, and then at a later stage lead an inspection with the experienced colleague present as an observer. In this way they will learn the procedures used by the inspectorate and how judgement on GMP compliance is exercised in real-life situations.
Inspectors need to update their knowledge, for example of advances in pharmaceutical and information technology, microbiology and statistical aspects of quality control. This can be done by a combination of reading, attending courses, conferences etc.
The "WHO Quality Systems Requirements for Inspectorates" recommends that inspectors be provided with at least 10 days of training per year.