Validation Procedures -TF.docVIP

PURPOSE:目的 To ensure that new equipment, molds and processes and changes to existing equipment, molds and processes result in consistent quality product prior to release to Manufacturing. 为确保在制造使用前，新设备，模具，制程和现有设备，模具，制程的任何更改不影响产品质量 SCOPE:范围 Applies to all equipment, molds and processes to be used in the Thermo Fisher Scientific – Rochester facilities related to the quality of the product or Quality System. 适用于所有用在Thermo Fisher Scientific – Rochester的相关产品质量和系统的设备，模具，制程 This procedure does not include sterility validation which is covered under STP-2029 Test Procedure for Validation of Sterilization. 本程序不包括STP-2029 消毒确认程序 This procedure does not apply to equipment, molds or processes implement prior to 7/11/97. Equipment installed prior to 1997 is considered as validated and re-validation will be considered as changes are made to the equipment as per section 5.1.2. 本程序不适用于7/11/97.前购买的设备，模具或实施的制程， 按5.1.2，当7/11/97.前安装的设备有变更时，应考虑重新确认。 DEFINITIONS:定义 Installation Qualification – a checklist of items that needs to be checked prior to starting up of the equipment to ensure that it is properly installed. 安装确认-在设备运行前，为确保正确安装，需按安装确认清单检查 Operational Qualification – a checklist of items that needs to be checked to ensure that the equipment operates as expected under ideal conditions 操作确认-为确保设备在预期的理想.状况下运行，需按操作确认清单检查 Performance Qualification – a demonstration of consistency of the equipment, mold and process under production conditions. 性能确认-为证明设备，模具，制程在批量生产情况下，能持续地按预期运行 QE – Quality Assurance Engineering. QE-品质保证工程 Product Release Criteria – Product is released for shipment as defined in the validation protocol, where applicable. 产品放行标准-适用时，产品按确认协议中规定的放行标准出货 Access database – database used to track and monitor validation activities. VP.mdb located in J:\QE\Validation directory 存取数据库-用于追溯和监控确认活动的数据库，J:\QE\Validation directory EQUIPMENT: 设备 N/A PROCEDURE:程序 Determine the need for validation: 确认需求 The department procuring new equipment, molds or processes, measurem