Control of Quarantined and Rejected Material
1. POLICY STATEMENT 方针说明
There must be Systems and Procedures to ensure that rejected, recalled or stock recovered, and Quarantined Active Pharmaceutical Ingredients (API), Drug Products, Raw Materials, intermediates and Packaging Components are controlled to prevent improper u or relea.
必须有系统和规程确保不合格的、召回的或物料回收的、待验的活性药物成分、药品、原材料、中间体和包材处于受控状态以防止不正确的使用或放行。
2. SCOPE 范围
This Standard applies to all Company Pharma Sites and Affiliates. The requirements of this Standard apply to all storage areas regardless of storage conditions.
此标准适用于制药公司及其分部。此标准的要求适用于任何储藏条件下的储藏区域。
3. RESPONSIBILITIES 责任
The site Quality Unit is responsible for approving or rejecting all Materials, and for the timely decision on rejected, recalled/recovered, and Quarantined Materials and communication of that decision to affected departments.
质量部门负责对所有物料的批准与拒收负责，并及时对拒收的、召回/回收的、和待验的物料做出决定，并把结论通知相关部门。
怎样挑选钻戒All Manufacturing, logistic and Warehou units are responsible for the proper control of rejected, recalled/recovered, and Quarantined Materials.
所有生产、后勤和仓储部门负责保证拒收的、召回/回收的、和待验的物料处于正确的控制之下。
Supply Chain, upon request from the Quality Unit, are responsible for the appropriate and timely disposition of rejected and Recalled/Recovered Materials. Finance and Environment Health Safety must be consulted as appropriate.
在质量部门要求时，供应链负责正确和及时地处理拒收和召回/回收的物料。处理前供应链应与财务和环境健康安全部门适当商量。
4. REQUIREMENTS 要求
There must be Procedures to define the Quality Status in u at each Site, and the must include as a minimum approved, Quarantined, and rejected.
竹匾的意思必须有规程定义（物料）在使用场所的质量状态，质量状态至少必须是批准、待验或拒收。
Incoming Materials and returned goods must be placed under Quarantine Status.
去的文言文意思接收货物和退货必须放在待验区域。
美好生活的诗句
All Materials, unless identified as approved or rejected by the Quality Unit, must be considered to be in a Quarantined Status. The Materials may have an alternative Status identified as Unrelead or On-Test, but the bear the same restrictions as Quarantined.
除被质量部门确定为批准或拒收以外的所有物料都被认为处于待验状态。这些物料可处于两种状态之一：未放行或检测中，但它们都受到与待验品一样的限制。
The status must be clearly identified at all times. This can be accomplished by a physical Segregation or electronically by the u of a Validated, computerized Materials management System.
任何时候状态都应清楚地标识，这可以通过物理隔离或者使用验证过的计算机物料管理系统来完成。山楂片的功效与作用
There must be a cure, physically Segregated, properly labeled/identified area for the st
orage of Recalled/Recovered Product. 脸部皮炎
必须有安全的、物理隔离的、正确标记的区域贮存召回/回收产品。
Rejected Material must be status labeled and physically Segregated from Quarantine and relead Material as soon as possible. Electronic Segregation by the u of a Validated, computerized Materials management System in addition to employing reject status labels is considered equivalent to the above requirement.
拒收物料必须立即标记状态并与待验、放行物料物理隔离。使用验证过的计算机物料系统电子隔离加上使用拒收状态标记被认为与上述要求具有相同效果。
There must be at least a quarterly review of Quarantined and rejected Materials by the Quality Unit and Supply Chain to ensure the timely disposition of Quarantined Material and disposal and Documented destruction of rejected Material.
质量部门和供应链必须至少每季度检查待验和拒收物料一次，以确保及时处理待验物料，并记录拒收物料的销毁。
Special Site needs must be met for controlled substances or Materials with special safety requirements regarding Segregation and control. 处理英语短语
拔罐后痒对于受控的、对隔离和控制有特殊安全要求的物料来说，必须有符合要求的特殊场所。
All Status changes must be controlled by Procedures approved by the Quality Unit.
所有状态变更必须在质量部门批准的程序控制下（进行）。
