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Wednesday, March 7, 2018

FDA GUIDE TO Personnel responsibilities. 211.28



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, and arm coverings, shall be worn as necessary to protect drug products from contamination it’s include primary garments secondary garments and if applicable sterile garments shall be in place as necessary to protect drug products from contamination.

Personnel shall practice good sanitation and health habits.

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Only personnel authorised by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall 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 jeopardize 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.

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