Good Manufacturing Practices, Inc. is a full-service industrial engineering, system integrator, industrial controls, and automation solutions provider.
GMP Engineering Regulatory requirements, scientific basics and practical implementation proposals around the topic engineering. What requirements apply to the design, planning and (re)construction of premises? What measures are required to prevent cross-contamination? How can the suitability of premises be...
À propos de CONCEPT GMP ENGINEERING Depuis sa création en 1978, CONCEPT fournit des technologies pharmaceutiques conformes aux normes GMP à des entreprises pharmaceutiques, des entreprises de substances actives, des entreprises de biotechnologie ainsi qu'à des pharmacies d'hôpitaux. L'accent est...
Boutique process engineering company focused on custom design, project development and integration of process critical manufacturing equipment for the bio-pharmaceutical and GMP compliant industries.
测试测量仪器的校正和控制,其包括标准操作规程、记录、接受限度、弥补行动、可追踪的标准,Engineering工程,Procedures to control document distribution and approval 文件分发及批准的标准操作规程 Procedures for Approval of changes to documents and communication of changes to 45、 personnel 文件变更批准及通知人员有...
ECR (Engineering Change Request)工程变更申请:通常使用於新产品完成后,非工程单位就本身之需要发出工程变更申请,交工程单位研究,工程单位若同意则发出ECO,交各单位会签,会签同意后导入。ECA (Engineering Change Authority)工程变更授权:有些时候工程变更需要经过客户的授权,此时则需要发出ECA要求客户签回,作为ECO的依据...
GEP(Good Engineering Practice):工程设计规范 HVAC(Heating Ventilation and Air Conditioning):空调净化系统 DQ(Design Qualification):设计确认 IQ(Installation Qualification):安装确认 OQ(Operational Qualification):运行确认 PQ(Performance Qualification):性能确认 OOS(Out-Of-Specification):检验不合格;超标 PFDS(Proce...
GEP=good engineering practice就和工程相关性非常密切了。 2.GEP 一般而言,我们把和生产紧密相关的工程部分纳入我们的GEP范围 对于制药行业而言,工程上会把和制药过程有无密切接触作为划分系统的标准,也就是说对于 密切和制药生产过程接触的系统,比如室内空气,生产纯净用水,生产纯净用蒸汽,室内的洁净室建筑,自动控制SC...
Provide efficient and cost effective utility supply and engineering maintenance services Set up and improve facilities management system Principle Roles & Responsibilities / Accountabilities(Major functions of the position) Responsible system: GMP related Facilities & Utilities, such as, HVAC, BAS/BMS, cle...
7、odEngineeringPractice):工程设计规范HVAC(HeatingVentilationandAirConditioning):空调净化系统DQ(DesignQualification):设计确认IQ(InstallationQualification):安装确认OQ(OperationalQualification):运行确认PQ(PerformanceQualification):性能确认OOS(Out-Of-Specification):检验不合格;超标PFDS(ProcessFlowDiagrams):工艺流程图MRA...