T/CACM 1607-2024 Guidelines for Quality Control Techniques in the Manufacture of Traditional Chinese Medicines
T/CACM 1607-2024 Guidelines for Quality Control Techniques in the Manufacture of Traditional Chinese Medicines
Basic Information
Scope
Main technical content: Preface II. Introduction III. 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Basic principles 5. Quantity value transmission 6. Pharmaceutical process materials 7. Pharmaceutical process parameters 8. Common control methods in pharmaceutical processes 8.1. General requirements 8.2. Release control 8.3. Endpoint control 8.4. Feedforward control 9. Application of process control methods 10. Requirements for core production equipment 11. Other key points of pharmaceutical process quality control 11.1. Continuous improvement 11.2. Integration of management and control Appendix A (informative): Quantity value transmission Appendix B (informative): Endpoint control and feedback control Appendix C (informative): Feedforward control References