The National Medical Products Administration Has Officially Released the Guiding Principles for Quality Management in the Production of Cell Therapy Products (Trial)
Release Date:
2023-02-02 17:03
Source: Center for Drug and Food Review and Inspection, National Medical Products Administration
On October 31, the Verification Center of the National Medical Products Administration officially released “Guidance on Quality Management for the Manufacture of Cell Therapy Products (Trial)” comprises thirteen chapters, covering the fundamental principles of GMP management for cell therapy products, as well as personnel, premises, facilities and equipment, donor screening and donor materials, materials and products, manufacturing management, quality management, and the product traceability system. and other content, as follows:
Guidance on Quality Management for the Production of Cell Therapy Products
(Provisional)
Center for Drug and Food Review and Inspection, National Medical Products Administration
October 2022
Table of Contents
I. Purpose
II. Legal Basis
III. Scope
IV. Principles
V. Personnel
VI. Factory Buildings, Facilities, and Equipment
VII. Donor Screening and Donor Materials
VIII. Materials and Products
IX. Production Management
X. Quality Management
XI. Product Traceability System
XII. Other
XIII. Terminology
I. Purpose
China’s cell therapy product sector is currently in a phase of rapid development. To further promote the healthy development of this field, and based on current scientific understanding and the state of technological advancement in cell therapy products, this Guidance has been formulated. Its primary purpose is to refine and enhance the technical requirements for quality management during the industrialization stage of cell therapy product manufacturing, with the aim of providing guidance to manufacturers of such products. At the same time, it can also serve as an important reference for regulatory authorities conducting various on-site inspections. Given the rapid growth of the cell therapy industry and the continuous emergence of innovative technologies, more advanced and sophisticated quality-management techniques may emerge in the future, potentially rendering certain provisions of this Guidance no longer fully aligned with current practices. In such cases, manufacturers are encouraged to submit detailed explanations, along with sound and comprehensive supporting rationale and evidence, to demonstrate the controllability of their quality-management systems. As scientific and technological advances continue, our understanding deepens, and experience accumulates, the content of this Guidance will be progressively revised and refined over time.
II. Legal Basis
1. Drug Administration Law of the People’s Republic of China
2. Implementing Regulations of the Drug Administration Law of the People’s Republic of China
3. Biosecurity Law of the People’s Republic of China
4. Pharmacopoeia of the People’s Republic of China
5. Measures for the Administration of Drug Registration
6. Measures for the Supervision and Administration of Pharmaceutical Production
7. Good Manufacturing Practice for Pharmaceuticals and its Appendices
8. Regulations on the Administration of Drug Registration Verification
9. Measures for the Reporting and Monitoring of Adverse Drug Reactions
10. Measures for the Administration of Drug Recalls
11. Regulations on the Management of Drug Package Inserts and Labels
12. Principles for Risk Assessment in On-site Inspections of Pharmaceutical Manufacturing Enterprises
13. Regulations on the Management of Medical Waste
14. Regulations on Biosafety Management of Pathogenic Microorganism Laboratories
15. Manufacturing and Testing Procedures Approved by the Drug Administration Authority
III. Scope
(1) The cell therapy products referred to in this Guidance (hereinafter “cell products”) are human-derived live-cell products that have been approved for marketing as pharmaceuticals and prepared through appropriate ex vivo manipulations, such as isolation, culture, expansion, and genetic modification. These include both genetically modified and unmodified cells, such as autologous or allogeneic immune cells, stem cells, tissue cells, and cell lines; however, they do not include blood components used for transfusion, hematopoietic stem cells for transplantation that are already subject to specific regulatory provisions, reproductive-related cells, or tissue and organ products composed of cells.
(2) This guideline applies to the entire process of cell products, from the transportation and receipt of donor-derived materials, through product manufacturing and testing, to finished-product release, storage, and transportation.
The manufacturing, testing, and release of gene-modifying vectors or other materials that confer specific functions to cell-based products—such as viruses, plasmids, RNA, antigenic peptides, antigenic proteins, and protein–RNA complexes—shall comply with the requirements of the Pharmaceutical Production Quality Management Regulations and their relevant annexes.
(3) Given that the donor materials for cell-based products are derived from human sources, their manufacturing must also comply with relevant national regulations on biosafety and the management of human genetic resources to prevent the introduction or transmission of infectious disease pathogens.
IV. Principles
(1) Cell product manufacturing has the following specific characteristics:
1. Donor materials are derived from human sources and may contain pathogens of infectious diseases.
2. The quality of donor-derived materials is variable and influenced by factors such as their source, type, and characteristics. The manufacturing process for autologous cell products must fully account for these individual differences in donor materials, establish appropriate process steps and parameters, and implement production within the scope of approved protocols.
3. Depending on the source of donor materials and the type of product, batch sizes can vary significantly, allowing for relatively flexible manufacturing organization and closer alignment between production and clinical needs.
4. Temperature and duration have a more pronounced impact on the quality of donor materials and products.
5. Because cell-based products consist of living cells and contain nutrients essential for cell survival, any contamination that occurs during the manufacturing process following donor material collection creates favorable conditions for microbial proliferation and spread, and since these products cannot be subjected to terminal sterilization, such contamination is difficult to eliminate.
6. Autologous cell products, or products manufactured using allogeneic donor-derived materials that are intended for use only after HLA matching with the patient, may result in life-threatening adverse outcomes if confusion or errors occur, leading to a mismatch between the donor-derived materials or cell product and the recipient.
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