The quality of the tissues and cells provided by Cell and Tissue establishments is important to the quality of the final product for human applications. Cells and Tissues by their very nature, inherently, pose a potential risk to recipients than conventional medicines that may have a sterilization process included in their manufacture.
The aim of GTP is to prevent cell and tissues products with infectious disease agents and to ensure that these cells and tissues maintain their integrity and function. This guide only focuses on cell and tissue establishments. Reference on detailed methods such as cleanroom classification and monitoring, qualification, validation and quality risk management should be made to other documents such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products Part I and its Annexes. In certain cases, other national regulations or standards may be applicable for cell and tissue establishment whereby it may provide technical requirements for the donation, procurement and testing stages. Cell and tissue establishment shall be responsible to adhere to these requirements (if any) and it must be done in accordance with an appropriate quality system.