2.0 - Personnel Overview 211.87 Any physical plant you use

Any physical plant you use in the manufacture

container damage or broken seals

Each of these supervisors must be qualified by education

and released for use by the quality control unit

follow and maintain written procedures for laboratory operations

2.0 - Personnel Overview 211.87 Any physical plant you useThere must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, relevant to their needs