The manufacturer should provide training in accordance with a written programme for all the personnel (including the technical, maintenance, and cleaning personnel) whose duties take them into production areas or into Quality control laboratories and for such other personnel whose activities could affect the quality of the product.

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 should be periodically assessed. Training programmes should be available approved by the heads of the concerned departments and head of QA.

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 job specific training.

The concept of quality assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.

Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, Particularly about personal hygiene and the necessity of entering in prescribed protective clothing. They should be closely supervised.