Application of the principles of good manufacturing practices (GMP) to the design and operation of a tissue culture laboratory

Abstract

Recommendations are presented for the design and operation of a tissue culture laboratory to reduce microbial contamination of cultures. These recommendations are based on practices currently used in the manufacturing of sterile drug products, certain medical devices, and in vitro diagnostic products. The recommendations depend on qualification and validation of equipment, systems, and procedures and on the control and monitoring of the laboratory environment and procedures.