There is also a own definition for the term “validation“ (“Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results”). The term “retrospective validation“ is not listed but the term “revalidation“ - also in the ...
■■ the cleaning procedures (documented in an existing SOP, including definitionof any automated process) to be used for each product, each manufacturingsystem or each piece of equipment; 为每一产品、每一制造系统或每一设备所采用的清洗程序(已编制在现行SOP中...
Examples of documentation for transfer of technology (TOT) 技术转移文件举例(TOT) Key task 关键任务 Documentation provided by SU 转出方提供的文件 Transfer documentation 转移文件 Project definition 项目定义 Project plan and quality plan (where separate documents), protocol, risk assessments, gap analysis...
aThe requirements for Quality Assurance, as outlined in this Section and elsewhere in this Specification, shall apply to Cont ractor as well as Contractor 's subcontractors to any tier who shall fu 要求的质量管理,如这个部分所述和在别处在这个规格,将适用于Cont ractor并且承包商‘s转承包商对将fu...
of systems, the term “process validation” could also be used. There is also a own definition for the term “validation“ (“Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results”). The term “retrospective validation“...
QAS Terminology db - List of Terms and related guidelines Term Related reference(s) Definition Abuse of scheme Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. (34th report, 1996) See sections 4.9 and 5.2 of ...
4.1Cleaning validation should be described in cleaning validation protocols, whichshould be formally approved, for example, by the quality control or qualityassurance unit. 清洁验证应在清洁验证方案中进行描述,该方案应得到正式批准,例如由质量控制或质量保证部门批准。
quality.”[1]A system where everyone truly owns quality requires acultureof quality. Without such a culture, all teams will make sacrifices against quality. Development teams may skip code reviews to save time, program management may cut corners on a specification, or fudge a definition of “...
Table 2 表2 Examples of documentation for transfer of technology (TOT) 技术转移文件举例(TOT ) Key task Documentation provided by Transfer SU documentation 关键任务 转出方提供的文件 转移文件 Project definition Project plan and quality plan Project implementation (where separate documents), plan 项目...
• definition and management of appropriate roles and responsibilities for quality agreements and contracts entered into by contract givers and contract acceptors. • 作为合同委托方或接受方签署的质量协议和合同中适当角色与职责的定义和管理。 2. SC...