SOP
SOP is a standard operating procedure.
It refers to a procedure that has been documented and approved to ensure that work is always performed in the same way, with the aim of constantly producing products having the quality equivalent of pre-established product specifications.
In the manufacturing of regenerative medical products, it is necessary to build a quality management system for production control, quality control, and buildings and facilities control that are in accordance with both (current) Good Manufacturing Practice ((c)GMP) and Good Tissue practice (GTP), or Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP), which is a quality control standard set by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Ministry of Health, Labor and Welfare (MHLW), respectively.The premise of GCTP is equivalent to the GMP (Good Manufacturing Practice) three principles*, and SOP needs to be created based on that premise.
When creating an SOP, it is necessary to confirm the robustness of the manufacturing conditions and procedures by repeating the processes, such as manufacturing and quality controls, that are to be standardized within a certain range of conditions and procedures.
* GMP three principles
･ Minimizing human error
･ Minimizing contamination and degradation
･ Build a reliable quality assurance system
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