Japanese Regulation: GCTP (Good Gene, Cell & Tissue Practice)

       GCS provide services for developing of CMC (Quality) of regenerative medical medicine
          according to GCTP (Japanese Ordinance) and GCT (FDA Regulation) in Japan

    • Consulting Services by GCS
    •   1. GCS evaluate the development products which are in manufacturing in compliance with Japanese standard for biological
          ingredients. GCS is going to summarize the study results of virus clearance and to take measures with regard to virus
          inactivation or removal ability of the virus when viruses are inactivated or eliminated in the manufacturing process
          regarding particularly raw materials.
    •   2. With respect to the manufacturing method and quality control of development products of regenerative medicine
         products, GCS will perform the following supports;
          ① Preparation to flow chart on manufacturing method
          ② Preparation of management examination list during the manufacturing process
          ③ Preparation of the list on specification test and test methods
          ④ With respect to characteristic analysis of processing cell
          ⑤ Safety evaluation of impurities remaining behind in the final product
          ⑥ Gap analysis of study results on manufacturing management and quality control between overseas and Japanese
            regulation requirements in the case of overseas advanced development or simultaneous development to evaluate
            the consistency in these study results world wide.
    •   3. Provide GCTP support to CMO (domestic and overseas) in which CMC regenerative medicine products is developed and
    •   4. Support a PMDA regulatory strategic meeting for overseas pharmaceutical company and medical device company, etc.
          to developregenerative medicine products, creating the meeting documents into Japanese to be included study results
          obtainedworldwide (of CMC, non-clinical and clinical)
    •   5. Support IND for regenerative medicine products in Japan and/or FDA
    •   6. Support application for manufacture and sales approval for regenerative medicine product in Japan and/or FDA