4 EMA 适用于监管机构在原料药生产商、进口商和分销商以及用作起始物料的辅料生产商或进口商的场所进行检查时的指南.pdfVIP

EUROPEAN COMMISSION HEALTHANDFOOD SAFETYDIRECTORATE-GENERAL Health systems,medicalproductsandinnovation Medicalproducts:quality,safety,innovation Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipientsusedasstartingmaterials 适用于监管机构在原料药生产商、进口商和分销商以及用作起始物料 的辅料生产商或进口商的场所进行检查时的指南 Tableofcontents目录: 1.