On October 31, 2022, in order to guide the drug MAH to standardize the production and quality management of cell therapy products, the National Bureau Verification Center issued the "Guidelines for the Quality Management of Cell Therapy Products (Trial)", which clearly explained the quality management of cell product production.
Key content
The cell therapy products (hereinafter referred to as cell products) described in this guideline refer to human living cell products prepared by appropriate in vitro operations (such as separation, culture, amplification, gene modification, etc.) approved for marketing according to the drug, including cells that have been or have not been genetically modified, but do not include blood components for transfusion, hematopoietic stem cells for transplantation that have been specified, reproductive-related cells, and tissues and organ products composed of cells;
This guideline applies to the entire process of cell products from the transportation, receipt, production and inspection of donor materials to the release, storage and transportation of finished products.
The production, inspection and release of gene-modified vectors or other materials that give them specific functions directly used in the production of cell products should comply with the requirements of the "Good Manufacturing Practice for Pharmaceuticals" and its relevant appendices.
Original notice
In order to guide drug marketing authorization holders to standardize the production and quality management of cell therapy products and ensure product quality, the Verification Center organized research and drafted the "Guidelines for Production Quality Management of Cell Therapy Products (Trial)", which is now released for reference.
This is hereby announced.
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