GMP Compliance Adviser Update No. 9/2017

GMP in Practice

Chapter 11 Production

11.A Industrial Hygiene

Industrial hygiene is the interaction between personnel and production hygiene. Industrial hygiene measures are absolutely necessary if pharmaceutical production is to be carried out in a GMP-compliant manner. The planning (material and personnel flow) and design (technical features) of the production rooms have a significant effect on the nature of the industrial hygiene measures required. Potential sources of contamination include personnel, starting materials, media, equipment, premises and the process itself. The adequacy of the industrial hygiene measures is monitored on a regular basis. The Head of Production is responsible for industrial hygiene in the manufacturing sector, and the Head of QC for the laboratory sector. Monitoring can be coordinated and evaluated by Quality Assurance in collaboration with Quality Control. (Christian Gausepohl, PhD)

11.B Personnel Hygiene

The requirements for work clothes are directly related to the cleanliness class in which the manufacturing process is carried out. The cleanability, particle release, adequacy and wear comfort of clothing must be taken into consideration as part of the selection process. The clothing must be washed (treated) in such a way that the quality of the fabric is not affected. A gowning instruction containing information about the clothing elements, the correct gowning procedure and changing of clothes should be available in each cleanliness zone and should be trained on a regular basis.

Hygienic behaviour is essential in all manufacturing areas. Special rules of behaviour apply to work that is carried out in clean rooms. Compliance with proper hand hygiene is extremely important.

Health surveillance is used to limit the potential risk of infectious diseases being passed on by personnel in ill health. Self-disclosure questionnaires or questionnaires completed in consultation with the occupational health practitioner are an important aspect of health surveillance.

Regular hygiene training sessions of a high quality are a key element in maintaining compliance with the hygiene requirements. An important aspect of training is the qualification of the gowning procedure. (Christian Gausepohl, PhD)