T/ZAITS 038-2025 Acquisition and processing guidelines for data of pharmaceutical manufacturing process
T/ZAITS 038-2025 Acquisition and processing guidelines for data of pharmaceutical manufacturing process
Basic Information
Scope
This document specifies the collection content, collection methods, information processing, and data control for pharmaceutical process information collection. This document is applicable to the collection and processing of information in all stages from the purchase of raw materials to the production of finished products for chemical drugs, biological drugs, and traditional Chinese medicines. 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Abbreviations 5. Collection content 6. Collection methods 7. Information processing 8. Data control Appendix A (informative) Case study of real-time measurement and control parameter collection for equipment Appendix B (informative) Data collection template