g. labels, leaflets, cartons, other printed items, etc.)?外包装材料(例如:标签、说明书、纸盒、其他印刷的材料等)?Technical changes related to labelling and artwork?与标签和样稿相关的技术变更?Analytical testing methods?分析方法?Analytical testing specifications?质量标准?Water systems?水系统?Cleaning and sanitization procedures?清洁和消毒程序РType of Change变更类型(total: 21)РSuppliers?供应商?Production site?生产地点?Stability (shelf life, retest period, storage and transport conditions)?稳定性(有效期、复检日期、储存和运输条件)?Quality and GMP related documentation?与质量和GMP相关的文件?Changes puter Systems and Software which may have an impact on system validation, product quality or GxP. ?由于变更计算机系统和软件而影响系统验证、产品质量或GxP?Change of supplier or third party; includes manufacturing, packaging, testing, warehousing, and distribution?变更供应商或第三方,包括生产、包装、检验、仓储和分销商?Change in release site(s)?变更放行地点
全文预览
