SOP on Personnel Responsibilities

1.0 Purpose: This SOP describes the requirements for the all the personnel working in the factory.

2.0 Scope: This SOP applies to all the personnel working in the manufacturing area and quality control laboratory.

3.0 Responsibility: Production Supervisor to ensure that the procedure is followed.

4.0 Materials and Equipment: None.

5.1 Personnel engaged in the manufacture, processing, packing or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand should be worn as necessary to protect drug products from contamination.

5.2 Personnel should practice good sanitation and health habits.

5.3 Only personnel authorized by supervisory personnel should enter those areas of the building and facilities designated as limited access areas.

5.4 Any person shown at any time (either by medical examination or by supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products should be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardise the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.