Quality control laboratory 实验室质量控制

9.1 Principle 原则

9.1.1 Principles described for personnel, premises, equipment, subcontracting, and documentation should apply to the quality control laboratory.

实验室质量控制应包括人员，职责、房屋设施、设备，分包和文件的控制

9.1.2 The quality control laboratory is responsible for ensuring that the necessary and relevant controls,within its activity, are carried out for sampling and testing so that materials are released for use and products are released for shipment, only if their quality fulfils the required acceptance criteria.

实验室质量控制的职责是对抽样，测试进行相关控制以确保原料可放行、成品可装运，当然是在质量符合标准的前提下。

9.2 Test methods 测试方法

9.2.1 The quality control laboratory should use all test methods necessary to confirm that the product complies with acceptance criteria.

实验室应采用各种方法证明产品是符合可接收准则的。

9.2.2 Controls should be performed on the basis of defined, appropriate and available test methods.

控制方法是建立在制订的正确、可行的测试方法基础上的

9.3 Acceptance criteria 接收标准

Acceptance criteria should be established to specify the requirements to be met for raw materials, packaging materials, bulk products and finished products.

接收准则应规定对原料，包材，散装产品，成品要求。

9.4 Results 结果

All results should be reviewed. After this review, a decision should be made, notably in terms of approval,rejection or pending.

对每个测试结果进行审核，详审后应做出判定，尤其是接受、拒绝或待定的决定。

9.5 Out-of-specification results 超出标准的结果

9.5.1 Out-of-specification results should be reviewed by authorized personnel and properly investigated.

超出标准的结果需经相关人员审核并分析。

9.5.2 There should be sufficient justification for any re-testing to be performed.

重新测试需要充分的理由。

9.5.3 After the investigation, a decision by authorized personnel should be made, notably in terms of deviation, rejection or pending.

分析后，授权人员要对偏差、拒绝或待定作出判定。