1.0 目标
制定重新处理和返工的程序。
2.0 范围
该程序适用于片剂的重新加工和返工操作。
3.1.2. 按照规定的程序进行重新处理。
3.1.3. 调查重新处理的原因。
3.2.2. 确保在开始重新处理操作之前，偏差处理表单已经得到适当的授权。
5.2. 生产部门和质量保证部门必须进行详细调查，以确定重新处理的原因，并制定相应的纠正措施。
5.3. 必须准备一份调查报告，该报告需由生产主管、质量保证（QA）主管、部门负责人签字，并经单位负责人和质量主管批准。
5.4. Once the corrective action plan is finalized, the batch must be recalled for reprocessing. Additionally, the production department must submit a deviation report in duplicate.
5.5. 相关负责人需填写偏差报告表，详细说明涉及的产品、批次编号、所遵循的标准工艺以及偏离的标准工艺，并提供偏离的合理理由。
5.6. 当所有细节填写完成后，表格必须由部门负责人签字，并附上他的意见或备注。
5.7. 质量保证部门分配的偏差报告编号（高级编号）。
5.8. 最后，质量主管和部门主管会在偏差处理表上签字并附上他们的意见/批准。
5.9. 完整填写的偏差处理表原件需交至质量保证（QA）部门，相关部门也会保留一份副本。
5.10. 一旦此流程完成，就必须按照偏差报告和调查报告中的要求启动重新处理流程。
5.11. If any material needs to be purchased from the warehouse for further processing, a requisition must be generated and signed by both the production department and the Quality Assurance (QA) team.
5.12. Upon receiving a request from the Warehouse, a Material Requirements Order (MRO) is generated. This order is then signed by the Production department and authorized by the Quality Assurance (QA) department before it can be processed further.
5.13. After receiving the materials, the reprocessing procedure is initiated, and all relevant process data, including the timing of each step, are recorded in detail.
5.14. 所记录的数据必须附在相应的批生产记录（Batch Record, BMR）中。
5.15. If the entire batch needs to be reprocessed, a new Batch Manufacturing Record must be issued and filed, which will be included together with the original Batch Manufacturing Record.
5.16. The manufacturing date on the new batch production record (BMR) will indicate the month of the reprocessing, while the expiration date will remain the same as that stated in the original BMR.
3.0 责任
3.1. 生产
3.1.1. 根据规定的程序获得重新处理的授权。3.1.2. 按照规定的程序进行重新处理。
3.1.3. 调查重新处理的原因。
3.2. 质量保证
3.2.1. 确保重新处理过程严格按照规定的程序进行。3.2.2. 确保在开始重新处理操作之前，偏差处理表单已经得到适当的授权。
4.0 责任制
4.1 质量保证经理5.0. 程序/步骤
5.1. 片剂/胶囊的重新加工可以在生产的任何阶段进行，从制造过程开始，一直到收到来自市场的投诉后的退货材料为止。5.2. 生产部门和质量保证部门必须进行详细调查，以确定重新处理的原因，并制定相应的纠正措施。
5.3. 必须准备一份调查报告，该报告需由生产主管、质量保证（QA）主管、部门负责人签字，并经单位负责人和质量主管批准。
5.4. Once the corrective action plan is finalized, the batch must be recalled for reprocessing. Additionally, the production department must submit a deviation report in duplicate.
5.5. 相关负责人需填写偏差报告表，详细说明涉及的产品、批次编号、所遵循的标准工艺以及偏离的标准工艺，并提供偏离的合理理由。
5.6. 当所有细节填写完成后，表格必须由部门负责人签字，并附上他的意见或备注。
5.7. 质量保证部门分配的偏差报告编号（高级编号）。
5.8. 最后，质量主管和部门主管会在偏差处理表上签字并附上他们的意见/批准。
5.9. 完整填写的偏差处理表原件需交至质量保证（QA）部门，相关部门也会保留一份副本。
5.10. 一旦此流程完成，就必须按照偏差报告和调查报告中的要求启动重新处理流程。
5.11. If any material needs to be purchased from the warehouse for further processing, a requisition must be generated and signed by both the production department and the Quality Assurance (QA) team.
5.12. Upon receiving a request from the Warehouse, a Material Requirements Order (MRO) is generated. This order is then signed by the Production department and authorized by the Quality Assurance (QA) department before it can be processed further.
5.13. After receiving the materials, the reprocessing procedure is initiated, and all relevant process data, including the timing of each step, are recorded in detail.
5.14. 所记录的数据必须附在相应的批生产记录（Batch Record, BMR）中。
5.15. If the entire batch needs to be reprocessed, a new Batch Manufacturing Record must be issued and filed, which will be included together with the original Batch Manufacturing Record.
5.16. The manufacturing date on the new batch production record (BMR) will indicate the month of the reprocessing, while the expiration date will remain the same as that stated in the original BMR.
6.0 缩写词
6.1 标准操作规程（SOP）6.2 BMR：批生产记录
6.3 质量保证（QA）