变更控制评估方案(1).docVIP

F9.002 (2) – 02 PAGE PAGE 1 变更控制评估方案 Change Control Committee Protocol 编号No.: GZCC-2005-0021 方案填写说明Instruction: 变更申请人需填写以下第1-8项和第19项内容. Proposer must fill in item 1-8 and 19. 对于第8项,只填写本次变更所涉及的内容,请附详细书面证据或试验报告. Regarding item 8, just fill in contents related to current Change Control. Please attach detailed evidence and validation report. 本方案经变更申请部门经理批准后交变更控制委员会协调员(QS主管).Current Change Control should be submit to Change Control Coordinator (QS Supervisor) after approved by manager of proposing department. 方案正文Protocol Details: 变更申请部门/人（签名）Prepared by: Fion / QA Department 变更申请部门经理（签名）Approved by: Elena / QA Department 变更实施日期Date project was initiated: 2005.07.05 变更内容Describe the change in detail: 蔗糖粒度的检测方法，除QWP规定方法（G415）外增加方法G4812 Testing method for particle size of sucrose were implemented according to G415,also G4812. 变更的原因What is the rationale for the change? 当检测精幼糖时，因粒度过细，易形成sample “balls”，用振荡仪不易过筛 (可能)受变更影响的产品List all products affected by this proposed change: EFG、EFGA+、EFKA+、ALA2、ALA3、SUS (可能)受变更影响的物料List the materials that are affected: NA (可能)受变更影响的供应商List the supplier sites that are affected: NA 变更被认为(应考虑) Changes to be considered: 过程和设备的变更: Process and Equipment Changes: NA 1. 软件Are software changes involved: 2.实际的工艺参数Actual process equipment changes: 2. 新配方的生产工艺条件Thermal process conditions programs for new formulations: 3. 设备 (新设备，设备改造，安全防护设施) Misc. equipment changes (new, modifications, maintenance): 配方变更: Formulation Changes: NA 新配方: New formulations: 改良配方: Reformulations: 包装材料结构/组成变更 Packaging Component Changes: NA 原材料变更Raw Material Changes: NA 有过敏原问题吗 Are there any hidden allergens issues? 研发和法规部门部有提供有关原料组分中的过敏原、GMO? Has a material composition statement been provided for allergens, GMO, Kosher and Halal issues by Product Development and Regulatory Affairs? 我们已确认原料是无BSE(疯牛病) 危害的吗 Have we confirmed that the raw material is BSE free? 有我们应知道的添加剂吗 Are there any additives that we should be aware of? 原料的使用会改变营养标识或成份表吗 Will use of this in