A series of regulations and compliance standards govern the operation of a laboratory facility for handling, processing and storage human stem cells and  tissue, including:

• FDA Compliant Laboratory

• 21 CFR 210, 211, 600-680, 820, 1271Plan Do Check

• 21 CFR part 11 and part 58

• Registered Tissue Handling Facility

• International Air Transport Association (IATA)

• Department of Transportation (DOT)

• International Society of Biological and Environmental Repositories (ISBER)

• Parenteral Drug Association (PDA) guidelines for cold chain shipping

Back

Next