ICH Q7 API FDA inspection training Conferences&TrainingsonGMPandRegulatoryAffairs 讲座&培训GMP及药政 TheOrganisationCONCEPTHEIDELBERG Foundedon1April1978Europe‘sleadinginstituteoffurthereducationforthepharmaceuticalindustry-inthefieldofproduction,QAandregulatoryaffairs240GMP/FDAComplianceCoursesperyear...
Quality Guidelines 质量 Q1 Stability(稳定性) Q2 Analytical Validation(分析方法验证) Q3 Impurities(杂质) Q4 Pharmacopoeias(药典) Q5 Quality of Biotechnological Products(生物技术产品的质量) Q6 Specifications(质量标准) Q7 Good Manufacturing Practice(生产质量管理规范) Q8 Pharmaceutical Development(药品研发) ...