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
    　　　 manufactured.
  • 　　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