(2003; 148 pages)
9.2 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 so as to present any risk to quality.
9.3. All responsible staff should have their specific duties recorded in written descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. 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.
9.4 All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs. All personnel should be motivated to support the establishment and maintenance of high-quality standards.
9.5 Steps should be taken to prevent unauthorized people from entering production, storage and quality control areas. Personnel who do not work in these areas should not use them as a passageway.