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- 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 develop regenerative medicine products, creating the meeting documents
into Japanese to be included study results
obtained world wide (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
