Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06 - admin@ich.org, http://www.ich.org Dated : 10 June 2015 Q7 Q&As In order to facilitate the implementation of the Q7 Guidelines, the ICH Experts have developed a series of Q&As: Q7 Q&As Document History Code Q7...
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) ...