Personnel who are supervising or performing drug manufacturing or control can be a potential source of microbiological contamination and a vector for other contaminants.
The main reasons for contamination from the personnel include:
- Lack of training
- Direct contact between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product
- Inadequate personnel cleanliness
- Access of unauthorized personnel into production, storage, and product control areas
- Inadequate gowning and personnel protective equipment
- Malpractices like eating food, drinking beverages, or using tobacco in the storage and processing areas.
