各种QA/QC SOP和表格、GMP/GLP质量手册、验证方案等，详见目录 Standard Operating Procedures Policies Qualification/Validation Documents Standard Operating Procedures Organization and Personnel SOPs QA/QC Department Job-Skill Training Training for Aseptic Processing Computer System SOPs Generating and Verifying Checksums Using MD5Summer Buildings and Facilities SOPs Biohazard Exposure Control Plan Cleaning and Sanitization of the Cleanrooms Equipment SOPs Operation and Maintenance of CO2 Incubators Operation and Maintenance of the Beckman GPR Tabletop Centrifuge Operation and Temperature Check of Dry Heat Baths Operating and Maintenance of the Drummond Pipet Aid Laboratory SOPs Lactic Acid Assay Recovery of Cryopreserved Cells Pseudorabies Virus Plaque Assay Removal of Adherent Cells from Tissue Culture Flasks XC Plaque Assay Assay for the Quantitation of Ammonia in Solutions Assay for the Detection of Murine Immunoglobulins Polio Virus Plaque Assay Cell Enumeration Using a Hemacytometer Production & Process Controls SOPs QC Inspection Requirements for Components & Finished Goods Device History Record Device Master Record, Use and Maintenance Production Documentation Flow General Scale Up and Maintenance of Cell Cultures Preparation of Materials for Bulk Filling Concentration of Bulk Antibody Gowning for Aseptic Filling General Cell Culture Guidelines Used in Manufacturing Validation SOPs Analytical Method Validation Procedure QVD Protocol and Report Preparation General Qualification and Validation Guideline Quality Assurance SOPs Discrepancy Report Procedure Out of Specification (OOS) Results Handling Product Recall Procedure, US Market Material Review Board Customer Complaint Procedure Good Documentation Practices Document Change and Control Procedure Material Control SOPs Raw Material Quality Assurance Procedure Manufactured Material Quality Assurance Procedure Rejected Materials Disposition Procedure Cell Culture Fluid Waste Disposal Clinical SOPs Audits of Clinical Research Informed Consent Procedure Monitoring of Clinical Trials Creating & Using an Investigator's Brochure
Policies Quality Manuals GMP Quality Manual GLP Quality Manual Personnel POLs QA/QC Authority and Responsibilities Production & Process Control POLs Antibody Product Change Over
Qualification/Validation Documents Computer Related Systems QVDs Windows 2000 Server Installation/Operational Qualification Windows 2003 Server Installation/Operational Qualification MD5 Summer Installation/Operational Qualification Equipment QVDs 2 to 8C Cold Room Installation Qualification Protocol 2 to 8C Cold Room Installation Qualification Report
DoxPub[1]
赛默飞实验室产品焕新计划有奖调研！
【七月征文】不一YOUNG实验“猿”
报名开启：ICS2024第十三届光谱网络会议！
推荐收藏！盘点中药材及饮片检测解决方案
