In the past ten years, stem cell research has made progress as a new way to treat diseases in the fields of tissue engineering, regenerative medicine, cell and gene therapy. This has led researchers to create clinical-grade cell and tissue products. To make sure that the product is safe, effective, and of good quality, it must be carefully controlled during the process of going from research to clinical use. The regulatory body for the production of cell and tissue should have designed approved a current good manufacturing practice (cGMP) facility for making these clinical-grade cell and tissue-based products. The regulatory agencies around the world enforce cGMP, which is the system or practice that controls the authorisation and licensing of manufactured goods like drugs, food and drinks, cosmetics, medical devices, and cell and tissue-based products. The quality management system is the most important part of cGMP for controlling the manufacturing process (which includes quality control testing and release of cell therapy products), facility management (which includes design, environmental control and monitoring, maintenance, equipment, personnel access, cleaning), validation, personnel training, competency, and records. To make a safe and high-quality product for people to use, the cGMP facilities for cell and tissue therapy should be built to a higher standard and follow the pharmaceutical manufacturer's guidelines. The facility needs to have a cleanroom that is the right size and has different class or grade areas (Grade A, B, C, and D) based on how clean the air and particles are. The facility's environmental control, monitoring, and upkeep are very important to keep contaminants out and make sure it runs smoothly. Prior to the manufacturing and therapeutic release of cell and tissue-based products, the standard operating procedures (SOP) for all associated processes must be established and validated. This chapter will cover the cGMP quality system, facility management, making clinical-grade cell and tissue-based products, and ethical issues.