Certification of Areas for GMP compliance: (检验企业实施现行药品生产管路规范部门的标准操作规程) CFR 21 Part 11(Code of federal Registry Part11):联邦法规法典标题21第11部分 CGMP(Current Good Manufacturing Practice):现行药品生产质量管理规范 Change control form:也简称CCF 变更控制表 Change control:变...
Calibration: 校正或校准(对设备,仪器和衡器等的准确度进行校正) Certification of Areas for GMP compliance: (检验企业实施现行药品生产管路规范部门的标准操作规程) CFR 21 Part 11(Code of federal Registry Part11):联邦法规法典标题21第11部分 CGMP(Current Good Manufacturing Practice):现行药品生产质量管理规范 ...
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. (2) Persons using electronic signatures shall, upon agency request, provide additional certification ...
Certification of Areas for GMP compliance: (检验企业实施现行药品生产管路规范部门的标准操作规程) CFR 21 Part 11(Code of federal Registry Part11):联邦法规法典标题21第11部分 CGMP(Current Good Manufacturing Practice):现行药品生产质量管理规范 Change control form:也...
Content uniformity test: 产品含量均匀性测定 Container closure system:容器封闭系统 COA(Certification ofanalysis ):分析合格证书,检验报告或检验报告单 <D> Delayed release:延期放行 Design qualification: 设计确认 Dissolution test:溶出度测试 Deviation records:偏差纪录 ...
COA（Certification of analysis ）：分析合格证书 D Delayed release：延迟放行 Design qualification: 设计确认 Dissolution test：溶出度测试 Deviation records：偏差记录 DMF（drug master file）:药物主文件 Drug product：成品药 Drug substance：原料药 Dietary supplement：膳食补充剂 E EIR（Establishment...
(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. § 11.200 - Electronic signature components and controls. a) Electronic signatures...
COA（Certification of analysis ）：分析合格证书，检验报告或检验报告单 D Delayed release：延期放行 De...
signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signers ...
electronicsignaturesintheirsystem,usedonorafugust20,1997,areintendedtobethelegallybinding equivalentoftraditionalhandwrittensignatures. 1.Thecertificationshallbesubmittedinpaperformandsignedwithatraditionalhandwrittensignature,tothe OfficeofRegionalOperations(HFC-100),5600FishersLane,Rockville,MD20857. ...