T/CACM 1606-2024 Chinese medicine pharmaceutical process analysis technology guideline

Scope

Scope: This document defines the relevant terms and definitions of process analysis technology in traditional Chinese medicine (TCM) production, and provides guidance for establishing a process analysis system for TCM production. This document is applicable to TCM pharmaceutical manufacturers establishing process analysis technology systems for R&D products or marketed products. Relevant pharmaceutical, food, and health care product enterprises may refer to and use this document for reference. Main technical content: Foreword II. Introduction III. 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Determination of key quality attributes of TCM products 5. Material attribute analysis 6. Pharmaceutical process analysis 6.1. Overall process analysis 6.2. Overall parameter analysis 7. Determination of key parameters and their operating ranges 8. Design space 9. Pharmaceutical process detection 9.1. Selection of process detection technology 9.2. Composition of process detection system 9.3. Application of process detection technology 10. Pharmaceutical process modeling 10.1. Process modeling methods 10.2. Steps of model establishment 10.3. Common pharmaceutical process models 11. Continuous improvement 12. Appendix A (informative) 13. Appendix B (informative) 14. Appendix C (informative)

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