Scope
High level of sanitation and hygiene practised - in every aspect of manufacturing. It covers:
Personnel
Premises
Equipment and apparatus
Production materials and containers
Products for cleaning and disinfection
All potential sources of cross-contamination
The WHO GMP refers to sanitation and hygiene in part one, section 4. It makes the point that all aspects of manufacturing are affected by one or both of these factors.
Consideration must be given to all personnel, both direct operators and other staff who enter the manufacturing area for whatever purpose.
Then there are the premises in which manufacturing takes place. The level of attention to this aspect will vary with the operation that is carried out.
All equipment and apparatus used in manufacturing must be controlled, together with production materials and the containers in which they are held.
Production materials (if not handled properly) and the containers (if not properly cleaned) can contribute to dirt and contamination in the factory.
Secondary materials, such as cleaning agents and disinfectants, must be controlled to ensure that they do the job for which they are designed but do not cause any contamination to the product. Cleaning tools, such as mops and brushes, must also be controlled.
To summarize, the aim of sanitation and hygiene measures is to eliminate all potential sources of contamination and cross-contamination from all areas where the product is at risk.