Louisiana Administrative Code
Title 51 - PUBLIC HEALTH-SANITARY CODE
Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics
Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs
Section VI-1511 - Personnel [formerly paragraph 6:195]
Current through Register Vol. 50, No. 12, December 20, 2024
A. The personnel responsible for directing the manufacture and control of the drug shall be adequate in number, and in education, training and experience, or combination thereof, to assure that the drug has the safety, identity, strength, quality and purity that it purports to possess. All personnel shall have capabilities commensurate with their assigned functions, a thorough understanding of the manufacturing and control functions they perform and adequate information concerning the reason for application of pertinent provisions of this Part to their respective functions.
B. [formerly paragraph 6:196] Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesion that may adversely affect the safety or quality of drugs, shall be excluded from direct contact with drug products until the condition is corrected. All employees shall be instructed to report to supervisory personnel any condition that may have an adverse affect on drug products.
AUTHORITY NOTE: Promulgated in accordance with the provisions of §258(B) of Title 36, and Chapters 1 and 4 of Title 40 of the Louisiana Revised Statutes of 1950. See in particular, R.S. 40:4(A)(1)(a) and R.S. 40:601 et seq.
