(2003; 148 pages)
11. Personal hygiene
11.1 All personnel, prior to and during employment, as appropriate, should undergo health examinations. Personnel conducting visual inspections should also undergo periodic eye examinations.
11.2 All personnel should be trained in the practices of personal hygiene. A high level of personal hygiene should be observed by all those concerned with manufacturing processes. In particular, personnel should be instructed to wash their hands before entering production areas. Signs to this effect should be posted and instructions observed.
11.3 Any person shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle starting materials, packaging materials, in-process materials or drug products until the condition is no longer judged to be a risk.
11.4 All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that they consider may adversely affect the products.
11.5 Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.
11.6 To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized.
11.7 Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material and personal medicines should not be permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality.
11.8 Personal hygiene procedures including the use of protective clothing should apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors’ employees, visitors, senior managers, and inspectors.