(2003; 148 pages)
10.1 The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required.
10.2 Besides basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness periodically assessed. Approved training programmes should be available. Training records should be kept.
10.3 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training.
10.4 The concept of quality assurance and all the measures which aid its understanding and implementation should be fully discussed during the training sessions.
10.5 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. They should be closely supervised.
10.6 Consultant and contract staff should be qualified for the services they provide. Evidence of this should be included in the training records.