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.