Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).你公司未能确保实验室包括有所有为确保符合既定质量标准而执行的检测中生成的完整数据...
THE LIFECYCLEAPPROACHReportable values generated using qualified analytical procedures provide the basis for key decisions regarding compliance of a test article with regulatory,compendial, and manufacturing...
Copyright ©2007-2022 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号