重新包装管理规程

规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 1 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 评估内容评估结果备注 是否涉及变更控制 是否需要开启 或已开启变更来评估制修订产生的 影响 是 否 NA 其他 如变更号 是否符合法规及注册标准要求 GMP 药典 国标 ISO 其他标准 是 否 NA 其他 是否涉及铅印 订做 请购 是 否如是 则列出所需铅印的内容 是否有记录需设置到电子系统中使 用 如 ERP 数据库 是 否如是 则列出所涉及的附录 是否合并规程 是 否如是 则列出所涉及的规程 是否需要采取其它行动 是 否 NA 其他 分发部门 价值流原液部 价值流制剂部 价值流供应部 价值流质量保证 科学技术部 技术支持部 环境健康安全部 产品放行 质量体系 质量验证 质量控制 质量改进项目部 其他 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 2 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 目目 录录 第一部分第一部分 正文正文 1 目的 第 3 页 2 适用范围 第 3 页 3 责任部门 人 第 4 5 页 4 定义和缩略语 第 5 6 页 5 物料和设备 第 6 页 6 规程 第 6 12 页 7 附件 第 12 页 8 附录 第 12 页 9 参考文件 第 12 13 页 10 注意事项 第 13 页 第二部分第二部分 正文附件正文附件 附件 A 第 14 15 页 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 3 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 产品重新包装管理规程产品重新包装管理规程 Product Reprocessing and Repackaging Management 1 目的目的 Objective Purpose 1 1 明确返工和重新包装的定义 Definition of Reprocessing and Repacking 1 2 明确返工要求和重新包装操作的管理流程 职责 Define Reprocessing requirement and the process and responsibility of Repackaging 2 适用范围适用范围 Scope 2 1 重新包装范围见下表 1 The scope of Repackaging is listed in table 1 below 2 2 TY 所有的商业产品均不得进行返工 重新加工 Reprocessing and reworking is not allowed for all commercial product in Tianyuan manufacturing site 工艺过程中适用与不适用重新包装的类型详见下表1 The table below details the types of repacking to which the process does or does not apply 重新包装种类重新包装种类 Types of Repacking 适用于适用于 Applies To不适用于不适用于 Does Not Apply To 所有第二次包装操作均发生在成品已经过QP放行或 其他同等批次放行流程放行后 和 或该产品已离开 原始生产地后 具体内容包括 All Secondary Packing Operations that take place after the finished product has been released following QP certification or equivalent batch release process and or has left the original manufacturing site including 外包装材料的变更 添加 替代和 或去除 Alteration addition substitution and or removal of secondary packaging 组分 例如 说明书 内盒 Components For example leaflets cartons 添加防篡改或防伪标志Addition of tamper evident or ant counterfeit features 禁止在西林瓶 安瓿瓶 注射器及任何疫苗产品的初次 包装上打印或覆盖贴标 任何重新包装发生在成品放行 之前和 或离开原始生产地之前 具体内容包括 Printing or over labeling on vials ampoules syringes and any vaccines product primary packaging as this is prohibited Any repacking which takes place before the finished product has been released and or has left the original manufacturing site This includes o任何工序涉及内包装材料破坏 或无菌生物制品包 装开口 破损 Any process that involves the breaking of the primary pack or blister opening breaching for sterile and biological products o质量许可情况下 在某一工厂对半成品做进一步处 理 贴标或包装 Semi finished product further processed by a site labeling and packaging and for which the activity is covered in Quality Agreement 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 4 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 由于产品需从一个市场转移到其他市场 重新 包装或重新贴标签以符合当地语言要求 Repacking or relabeling to meet local language requirements as a result of transfer of product form one market to anther market 初次包装后已放行到市场Packaging of primary packs released to the market o产品放行上市之前在原生产地进行的成品重新包装 Repacking of finished packs at original packing site before the product is released for sale o在产品内盒外添加VVM标签Add the VVM labeling on the carton 3 责任部门 人 责任部门 人 Responsible department person 关键的角色和职责KEY ROLES AND RESPONSIBILITIES 以下个人和团队有重要的角色和职责来完成重新包装流程 同一个人可能担任不止一个角色 保留必要的独 立批准职责 The following individuals and teams have key roles and responsibilities to fulfill in the Repacking process The same individual may perform more than one role provided the necessary independence of required approvals is maintained 商业角色商业角色Business Role关键职责关键职责Key Responsibilities 重新包装发起人 Repacking Proposer 评估重新包装 确保评估是基于商业 监管 市场及产品质量要求 To assess the repacking activity and ensure it is justified based on commercial regulatory market and product quality requirements 评估报告在重新包装开始前得到批准To obtain appropriate approval for the repacking before it starts 确保重新包装活动是有记录追踪的 To ensure that repacking activity is captured in a local tracker 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 5 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 质量部 Quality QAVS 确保重新包装的流程是有效的和健全的 重新包装符合该SMP要求 To ensure effective and robust processes are in place and in use to manage repacking in accordance with this SMP 审阅和批准重新包装申请 To review and approve repacking proposals 在重新包装开始之前获得适当额外的批准 To obtain appropriate additional approvals for the repacking before it starts 确保重新包装的设施能满足用途 例如符合要求 文件 设备及人员充足 To ensure that repacking facilities are fit for purpose i e comply with requirements and adequate documentation equipment and personnel are in place 确保任何发起的重新包装的法规影响经过评估和记录 否则委托给重新包装者或 原始制造地 必要时QS支持 To ensure that any regulatory implications of any proposed repacking have been assessed and addressed Unless delegated to the repacker or original manufacturing site 批准或拒绝与药品相关的重新包装的要求 To approve or reject repacking requests related to medicinal products 放行QA QP QP QA Release 审阅和批准重新包装申请 二级 To review and approve repacking proposals 确保所有重新包装的组分是完全受控的 To ensure all repacking components are adequately controlled 在年度APR中回顾重新包装的批次 To periodically review repacking batch in the APR Report 放行重新包装的材料 放行QA To release components for repacking QA Release 批准或拒绝与药品相关的重新包装的要求 二级 To approve or reject repacking requests related to medicinal products 按照法规要求放行重新包装产品 To release repacked products where required by regulations 仓库管理员 Warehouse Handler 把所重新检查和重新包装的批号分开存放 Segregate physically the recheck and repack batches and indicate in the inventory logbook 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 6 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 4 定义和缩略语定义和缩略语 Definition and abbreviation 重新包装 重新包装 任何内包装材料或者外包装材料的文字的更改 或去除或替换任何已打印外包装材料 并且操作 均发生在成品已按照QP放行或其他同等批次放行流程放行后 和 或该产品已离开原始生产地后 Any operation that Requires the alteration of text to primary or secondary packaging and or the addition removal or exchange of any printed secondary packaging material and takes place after the finished product has been released following QP certification or equivalent batch release process and or has left the original manufacturing site 5 物料和设备物料和设备 Materials and equipment N A 6 规程规程 Procedure 6 1 重新包装重新包装 6 1 1重新包装评估 参见附录重新包装评估 参见附录1 Assessment of Repacking 重新包装申请者必须评估重新包装开始之前所有行动是否合理 要求 The Repacking Proposer must assess if repacking is justified before starting any repacking activities They must 6 1 1 1评估重新包装的理由 Evaluate the reason s why repacking is required 由于偏差而需要重新包装时 确认必要的纠正预防措施已经完成 When required because of a deviation confirm that necessary corrective and preventative actions CAPAs are complete 6 1 1 2评估申请的重新包装的商业可行性 需考虑重新包装批次的成本 供应的重要性及再包装产品剩余保质 期 Evaluate commercial viability of proposed repacking taking into account total cost criticality of supply and extent of shelf life remaining for any repacked batches 6 1 1 3定义范围 比如包装需要改变 包装的数目 Identify what would be involved for example changes to be made to the pack number of packs to be processed 6 1 1 4评估在什么地方进行重新包装操作 确认以下内容被批准 Evaluate where the repacking operations would be conducted and confirm that the following are in place and approved A 供应的技术项目 Technical terms of supply B 对于第三方 第三方操作现场审计 技术 质量方协议和合同 For third parties Site audit for proposed activity technical quality agreements and contracts 6 1 1 5识别待供应的市场 法规及批次放行的影响 Identify markets to be supplied regulatory and batch release 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 7 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management implications 6 1 1 6识别任何重新包装操作过程中需要的环境控制 如在非冷藏条件下的储存时间 Identify any environmental controls required during repacking operations for example time out of cold store 6 1 1 7 识别任何与申请的重新包装相关的风险及任何的缓解行动 Identify any risks associated with proposed repacking together with any mitigation plans 6 1 1 8 确认防篡改或防伪标志是否会被破坏或者是否需要重新添加 Determine whether tamper evident or anti counterfeit features would need to be broken or are required and whether they must be reapplied or added 6 1 1 9 确认任何额外的测试或抽样的要求 Identify any additional testing and sampling requirements 6 1 1 10 确认批号的要求SOP QM 00 04 001 Identify batch number requirements See SOP QM 00 04 001 6 1 1 11 确保任何重新包装被当地的法规部门批准 如果需要 重新包装的申请人必须在重新包装申请单中 记录此评估以及重新包装的理由 必须记录清晰 详述重新包装的流程 包括任何重新包装操作的控制要求 然后评估报告须提交给质量进行批准 Ensure that any repacking is approved by local Regulatory Authorities if local regulations require it The repackaging proposer must document this assessment and rationale for why the repacking is justified in a repacking request form They must also document clear detailed repacking instructions including the controls required for any proposed repacking operation They must then submit the form to Quality for approval 一级评估包括 Level 1 assessment include 二级评估除了上述内容外 还包括 Level 2 assessment includes these items as below besides those in level 1 1 重新包装的原因 为什么需要重新包装 出错的 原因在哪里 是否己有针对这一原因的 CAPA The reason why the repack is required and where required as a result of an error and confirm that the necessary CAPA have been addressed 2 对法规和批放行的影响 Impact on regulatory and batch release 3 对产品质量的影响 如冷链条件包装完整性的影 1 在哪里进行重新包装 所有涉及产品组分或者打 印变化的重新包装必须在浙江天元生物药业有限公 司进行 Repack location All the repack operations related with component or overprinting changing must be executed in TY accept price label sticking 2 如为退货产品 应检查 检验和调查 并有证 据证明退货产品质量未收影响 且经质量管理部 门根据操作规程评价后 方可考虑将退货重新包装 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 8 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 响 混淆的风险 物料平衡的影响等 Impact on product quality Such as impact on cold chain packing integrity mix up and reconciliation 4 对追溯性的影响 哪些需要重新包装 如重新包 装则需要做哪些变动 重新包装的数量等 Impact on traceability Which portion need to be rechecked and repacked any change need to be done if there is repacking and the quantity need to be rechecked and repacked 5 确定防窃起特征是否需要破坏 添加 或重新 使用 To confirm if temper feature need to be broken added or re used 6 重新包装的商业可行性 总费用和对供应的影响 Impact on commercial viability total cost and criticality of supply 7 重新包装仍沿用以前的批号信息 Batch number will not be changed for repacking 8 留样 Determine retention samples 重新发运销售 评价考虑的因素至少应当包括药品 的性质 所需的贮存条件 药品的 现状 历史 以及发运与退货之间的间隔等因素 不符合贮存和 运输要求的退货应当在质量管理部门的监督下予以 销毁 对退货质量有怀疑时 不得重新发运 If the returned goods are going to be repacked they should be checked tested and investigated to prove that the quality is not impacted It should be assessed by quality department before return goods being repacked and shipped out The assessment should at least includes the product characters storage conditions the status and history of the products and time between shipment and return Goods that cannot meet requirement should be destroyed If there is any hesitate on quality of return goods they should not be shipped out 3 文稿变更 Artwork change 4 识别重新包装可能引起的其他风险及其缓解措施 Identify any risk associated with the proposed rechecking and repacking together with any mitigation plans Note 本 SOP 范围之外的情况在实施之前须得到总部机构的批准 In case there is other recheck or repack case out of the scope of this SOP Approved by quality groups prior to commencing recheck and repack 6 1 2 图案文稿及原材料批准图案文稿及原材料批准 Artwork and Materials Approval 如果需要重新创建新的图案文稿 则所有的与重新包装组分相关的打印材料和图案文稿必须采用图案文稿控 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 9 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 制程序进行批准 SOP QM 00 02 006 If there is a requirement to create new artwork then all printed materials and artwork relating to repacking components must be approved using Artwork Control Process refer to SOP QM 00 02 006 6 1 3重新包装批准重新包装批准 Repacking approval 质量部必须至少基于以下准则批准或拒绝评估 Quality must approve or reject the assessment based upon the following criteria as a minimum 6 1 3 1重新包装不涉及在西林瓶 注射器或疫苗产品上覆盖打印或增加标签 The repacking does not involve overprinting or adding labels to vials syringes or any vaccines products 6 1 3 2任何与重新包装产品相关的纠正预防措施已经完成 重新包装的厂房设施已根据GSK审计要求被批准用 于重新包装操作 Any CAPAs relating to product being repacked are complete Repacking facilities are approved for the type of repacking operation proposed following GSK audit 6 1 3 3重新包装的厂房设施相关供应或质量协议和合同的技术条款已准备就绪 以及与重新包装操作的类别 Technical Terms of Supply Quality Agreements and contracts with repacking facilities are in place and relate to the type of repacking operations to be performed 6 1 3 4 法规及批次放行要求能够满足 Regulatory and batch release requirements for the market can be met 6 1 3 5 与申请的重新包装的操作相关的风险包括环境控制和防篡改标已被充分评估及相应的降低风险的处理 措施可接受 Risks including environmental controls and tamper evidence associated with proposed repacking operations have been fully evaluated and any countermeasures proposed to mitigate risks are acceptable 6 1 3 6 批号 包装及包装的组分是匹配的及可追溯的 Batch number pack and pack components are suitable and traceable 6 1 3 7 额外的测试和抽样要求是符合重新包装需求 操作和法规要求 Additional testing and sampling requirements are appropriate for the product type repacking operation and market regulatory requirements 6 1 3 8 重新包装是否需要额外的质量批准 需考虑以下几点 if the repacking requires additional quality approval taking into account the following 正在重新包装的产品 Product being repacked 重新包装行动的性质 Nature of the repacking activity 重新包装的地点 例如 GSK 工厂或第三方工厂 Where the repacking is done i e GSK site or third party 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 10 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management facility 以下表格详述了不同的批准要求 如果某种特殊的重新包装行动没有在这个表格列举则采取最高的批准标准 The table below details the different approval requirements If a specific repacking activity is not listed in this table apply the highest level of approval Table 1 Approval levels for repacking activities 活动Activity级别 Level 组分更换 增加 移除 如说明书 外包装材料第二层包装 Exchange addition removal of component s leaflets secondary packs 2 增加防篡改和防伪 Addition of tamper evident or anti counterfeiting features 1 增加标签 不涉及注册内容 Addition of labels that do not obscure change registered text 1 使用说明使用说明 Key to table 1 1 价值流质量保证负责人批准价值流质量保证负责人批准 Approval by QAVS Lead 2 价值流质量保证负责人和价值流质量保证负责人和QP批准批准 Approval by QAVS Lead and QP 6 1 4 重新包装重新包装 Repacking 6 1 4 1重新包装准备 Preparing for repacking 质量部必须确保以下用于重新包装的要求达成 Quality must ensure that the following is in place and used for the repacking operation 适合的受控制区域 a suitable controlled area 批准的重新包装程序 包括额外标签或打印信息不会对原始信息产生影响 如 剂量信息 有效期 批号 或其他注册细节 approved repacking instructions including where to apply any additional labels or printing to not obscure primary information For example dosing information expiry date batch number or other registered details 人员培训trained personnel 印刷信息被批准的供应商打印并放行使用 并可以追溯 图案文稿参见SOP QM 00 02 006 components generated using approved artwork see SO P QM 00 02 006 printed by an approved supplier released for use and fully traceable 定义合适的 物料平衡定义 defined reconciliation limits suitable for the proposed repacking 6 1 4 2 实施重新包装 Carrying out repacking 6 1 4 2 1必须确保重新包装操作符合相应的程序 Quality must ensure that the repacking process complies with procedures applicable to the repacking activities including 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 11 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 环境控制 比如移出冷库后最大放置时间 TOR Special environmental controls for example maximum time out of cold store TOR 重新包装操作中间控制 In process controls appropriate to the repacking operation in place 区域 包装线清场参见SOP PR 07 05 008 SOP PR 00 05 026 需包括新包装材料进入前 原有的包装材料 的从包装现场移出 例如 更换说明书或包装盒 Area line clearance see SOP PR 07 05 008 SOP PR 00 05 026 which must include clearance of components removed from a pack For example changing a leaflet or carton before new components are introduced 安全处理被代替的和废弃包装材料 Secure disposal of replaced and waste packaging components See SOP QM 00 04 015 检测和采样要求Testing and Sampling requirements 6 1 4 2 2必须确保 They must also ensure that 所有包装活动是有追溯的 Traceability of all packs is maintained 重新包装产品的有效期不能改变 Expiry date of the repacked batches is unchanged 用于重新包装的材料样本需包含在批记录中 Samples of component s used in the repacking are included in the batch documentation 法定留样需根据当地法规要求管理 Retained samples are appropriately managed according to local legislation 重新包装第一时间 申请人和质量部门必须批准第一包装品 样本 后续操作可以基于首个包装品照片进 行Whenever conducting a repacking for the first time the Repacking Proposer and Quality must approve the first pack prototype They can do so based on photographs of the first pack sent by the repacker 6 1 5 重新包装后重新包装后 Post repacking The repacking proposer must record the complete history of the repacking activities 重新包装发起部门必须记录重 新包装活动的完成过程 6 1 6 批次放行批次放行 Batch release 6 1 6 1重新包装批次 或批次部分 放行前 为追踪重新包装的物料状态 质量部必须评估重新包装的各个方 面 Before releasing a repacked batch or part batch Quality must assess all aspects of repacking in order to progress the status of the repacked material 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 12 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management 6 1 6 2 需为符合批次放行管理程序 参见SMP G 00 QM 029 并审核批文件信息以确认批次适合上市 In accordance with batch release procedures see SMP G 00 QM 029 review the batch documentation and information available to confirm that the batch is suitable for sale 6 1 7 审核审核 Review 年度APR回顾中回顾重新包装的批次 以及重新包装操作过程中产生的额外行动 比如偏差 纠正预防措施 是否都已经执行 参见SMP G 00 QM 015 The repacked batches and additional actions during repacking e g deviation and CAPA actions implementation status need to be reviewed in APR See SMP G 00 QM 015 7 附件附件 Attachment 附件序号附件序号 Number 附件名称附件名称 Name 附件A Attachment A 重新包装流程 Repackaging Process 8 附录附录 Appendix 附录序号附录序号 Number 附录名称附录名称 Name 附录编号附录编号 版本号版本号 Number version 状态状态 多选 多选 Status 附录1 Appendix 1 返工登记台账GER SMP G 00 PR 028 01 05 新建 更新 未更新 废除 已废除 电子形式受控 NA 附录2 Appendix 2 产品返工管理规程考核试卷GER SMP G 00 PR 028 02 05 新建 更新 未更新 废除 已废除 电子形式受控 NA 附录3 Appendix 3 产品重新包装评估表GER SMP G 00 PR 028 03 01 新建 更新 未更新 废除 已废除 电子形式受控 NA 附录4 Appendix 4 产品重新包装管理规程考核 试卷 GER SMP G 00 PR 028 04 01 新建 更新 未更新 废除 已废除 电子形式受控 NA 9 参考文件参考文件 Reference documents 9 1 制订依据 GQMP5010 9 2 相关规程 规程编号 版本号 Number Version SMP G 00 PR 028 06 制 修订部门 Department QAVS 规程页码 Page of Pages 13 15 规程名称 Title 产品重新包装管理规程 Product Repackaging Management SMP G 00 QM 015 年度产品质量回顾