1. 目的 Purpose :
本规程为样品的保存与销毁提供了详细的标准程序。
2. 范围 Scope :
化验室
3. 责任 Responsibility:
QC 检验员/组长
QC analysts/Group Leader 4. 程序 Procedure : 4.1 样品的保留
Sample retain
4.1.1 保留所有研发及生产过程中产生的样品,包括客户提供的样品,新产品试
验样品,各种验证过程中抽走的样品,除另有要求外按上述规定保存。
Retains all samples generated in the development and production process, including sample provided by the customer, new test sample, siphoned samples in validation process, save as specified above unless otherwise requested. 4.1.2 较贵重样品可酌情留样。 Valuable samples may be retained. 4.2 样品储存 Sample storage
4.2.1 将所有留样登记(参见附录2) 。
Registration of all retaining samples(See appendix 2).
4.2.2 将所有的留样留存在留样室的样品架上,分类保存,明显标记。
Retain all samples on the sample holder in the retaining sample chamber, classification preservation, clearly marked.
4.2.3 留样室应保持18~26℃,RH45~65%并做到每日监控。
The retaining sample chamber should keep18~26℃,RH45~65%, and monitored daily.
4.2.4 针对样品的不同要求,选择具有避光,密封,干燥,冷却等性能的地点或容器储存样品。
For different samples, choose dark, sealed, dry, cool place or containers to store samples.
4.3 样品的使用 Sample Using
取用样品应登记,取用人应在留样使用登记卡(参见附录3) 上记录取用日期,样品名称,使用原由,使用量等必须内容。
Record sample date, sample name, use reason, usage amount on registration card when taking samples.
4.4 样品的销毁
Destruction of samples
4.4.1负责样品保管的人应在每年初按样品保管期限检查一次留样。将已到保管期的样品列表,提交QC 主管批准后交兼职安全员。
The person charged with the retaining sample should check the retaining sample by a retention period at the beginning of each year.
4.4.2 样品的销毁由兼职安全员,样品保管人员共同监督完成。
The destruction of samples should be supervised by both part-time security staff and sample keeper.
5. 分发部门
质量保证部、管理部
附 录 1:
附 录 2:
留 样 登 记 卡
附 录 3:
留 样 使 用 登 记 卡
1. 目的 Purpose :
本规程为样品的保存与销毁提供了详细的标准程序。
2. 范围 Scope :
化验室
3. 责任 Responsibility:
QC 检验员/组长
QC analysts/Group Leader 4. 程序 Procedure : 4.1 样品的保留
Sample retain
4.1.1 保留所有研发及生产过程中产生的样品,包括客户提供的样品,新产品试
验样品,各种验证过程中抽走的样品,除另有要求外按上述规定保存。
Retains all samples generated in the development and production process, including sample provided by the customer, new test sample, siphoned samples in validation process, save as specified above unless otherwise requested. 4.1.2 较贵重样品可酌情留样。 Valuable samples may be retained. 4.2 样品储存 Sample storage
4.2.1 将所有留样登记(参见附录2) 。
Registration of all retaining samples(See appendix 2).
4.2.2 将所有的留样留存在留样室的样品架上,分类保存,明显标记。
Retain all samples on the sample holder in the retaining sample chamber, classification preservation, clearly marked.
4.2.3 留样室应保持18~26℃,RH45~65%并做到每日监控。
The retaining sample chamber should keep18~26℃,RH45~65%, and monitored daily.
4.2.4 针对样品的不同要求,选择具有避光,密封,干燥,冷却等性能的地点或容器储存样品。
For different samples, choose dark, sealed, dry, cool place or containers to store samples.
4.3 样品的使用 Sample Using
取用样品应登记,取用人应在留样使用登记卡(参见附录3) 上记录取用日期,样品名称,使用原由,使用量等必须内容。
Record sample date, sample name, use reason, usage amount on registration card when taking samples.
4.4 样品的销毁
Destruction of samples
4.4.1负责样品保管的人应在每年初按样品保管期限检查一次留样。将已到保管期的样品列表,提交QC 主管批准后交兼职安全员。
The person charged with the retaining sample should check the retaining sample by a retention period at the beginning of each year.
4.4.2 样品的销毁由兼职安全员,样品保管人员共同监督完成。
The destruction of samples should be supervised by both part-time security staff and sample keeper.
5. 分发部门
质量保证部、管理部
附 录 1:
附 录 2:
留 样 登 记 卡
附 录 3:
留 样 使 用 登 记 卡