There shall be an adequate number of personnel at all levels having knowledge, skill and capabilities relevant to their assigned function, and capable of handling their duties properly. They shall have the attitudes for achieving the goals of Good Manufacturing Practice (GMP).
The manufacturer shall have an organisation chart. People in responsible positions shall have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There shall be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice. The organisational structure of the company shall be such that the Production and the Quality Control Departments shall be independent of each other. Key posts shall be occupied by full-time personnel (direct supervision during operation) and shall be given full authority necessary to execute his/her duties effectively. An adequate number of trained personnel shall be available to carry out the production and the quality control operations in accordance with established procedures and specifications.
