[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.28]

[Page 118-119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                  Subpart B--Organization and Personnel
 
Sec. 211.28  Personnel responsibilities.

    (a) 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.
    (b) Personnel shall practice good sanitation and health habits.
    (c) Only personnel authorized by supervisory personnel shall enter 
those areas of the buildings and facilities designated as limited-access 
areas.
    (d) 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

[[Page 119]]

products. All personnel shall be instructed to report to supervisory 
personnel any health conditions that may have an adverse effect on drug 
products.