The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
Responsible staff should have its specific duties recorded in written descriptions and adequate authority to carry out its responsibilities. Its duties may be delegated to designated deputies with a satisfactory level of qualifications. There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP. The manufacturer should have an organization chart.
All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, including hygiene instruction, relevant to their needs. All personnel should be motivated to support the establishment and maintenance of high quality standards.
Steps should be taken to prevent unauthorized people entering production, storage and QC areas. Personnel who do not work in these areas should not use them as a passageway.
