In general, hygiene in the broader sense means protection against diseases, contamination or spoiled food. In the GMP environment, it also means protection against unsafe medicinal products, complaints, losses and annoyance. Hygiene measures in the GMP environment serve to protect medicinal products and thus ultimately patient safety.
Personnel hygiene comprises measures that relate to employees. These are rules for health monitoring, employee training, e.g. on hygienic behavior in the cleanroom and the clothing concept. The GMP-relevant regulations require detailed hygiene programs to be drawn up for this purpose. This takes account of the fact that people are the main source of potential contamination.
Industrial hygiene, also known as production hygiene, is concerned with the premises and equipment. Industrial hygiene therefore includes the hygiene zone concept, rules for cleaning and for monitoring the hygiene status. Operating rooms and equipment must be cleaned regularly and, if necessary, disinfected and sterilized.
A hygiene plan summarizes all measures for personnel hygiene and operational hygiene. The hygiene plan also contains the monitoring measures and the measures to be taken if limit values are exceeded and special incidents occur. The persons responsible for implementing and complying with the measures are also listed.
