T/CGCPU 007-2019 Standard for Evaluating the Capacity of Biological Sample Analysis and Detection

Scope

Scope: The evaluation criteria for the analysis and detection of biological samples include organizational structure and personnel, experimental sites and environments, equipment, facilities and materials, systems and standard operating procedures (SOPs), management and implementation of experiments, quality and risk management, recordkeeping and document archiving, etc. This evaluation standard is applicable to self-assessment and/or third-party on-site evaluation of laboratories for the analysis and detection of biological samples in clinical trials. Main technical contents: 1. Scope 2. Normative reference documents 3. Terms and definitions, acronyms 3.1 Terms and definitions 3.1.1 Standard Operating Procedures (SOPs) 3.1.2 Quality Assurance (QA) 3.1.3 Quality Control (QC) 3.1.4 Monitoring 3.1.5 Audit 3.2 Acronyms 4. Evaluation content for the analysis and detection of biological samples 5. Determination of evaluation results Appendix A (normative appendix) Evaluation content and evaluation levels Part I: Organizational structure and personnel Part II: Experimental sites and environments Part III: Equipment, facilities and materials Part IV: Systems and standard operating procedures Part V: Management and implementation of experiments Part VI: Quality and risk management Part VII: Recordkeeping and document archiving

Development Information

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