T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products (English Version)
This guideline clarifies and requires the organization and personnel, plant and equipment, production management, material management, bacterial seed batches, process control, quality control, packaging and storage, transportation, etc. Production enterprises can standardize according to the requirements of this guideline. Plasmid production quality management further ensures product quality. This guideline fills the domestic gap in the production quality management of plasmids used in the production of in vitro gene modification systems for immune cell therapy products, and lays the foundation for further improving the regulatory and standard system for cell therapy products.
T/SHPPA 019-2023 history
2023T/SHPPA 019-2023 Guidance for the manufacturing quality management of plasmids used in the production of Immune cell therapy products