常见错误

清歌一曲月如霜

常见错误

1。否则执行良好的工艺流程，开始与的原料采样过程和重点obviouslyimportant阶段，如复合或灌装过程。

2。未按培训操作员， andfailure灌输一种高承诺：

最常见的错误，如不遵守程序，不采取样品在指定的时间，样品处理不当，没有报告在具体执行过程中，等的差异，削弱高品质的性能，并有助于成绩不佳。强烈建议有验证部门表示，从目前整个所有运行。


3。缺少或不准确的文件：

此外，上面提到的第2常见的错误，缺乏文档也造成困难的情况下，在今后的审计工作，因为在调查过程中重要的关键信息将会丢失。这是通常一般的基础的数据的误解。


4 。在验证过程中涉及的不同领域之间缺乏良好协调andcommunication的：

的协调和沟通不善的例子包括，不及时采取样品，所需材料可根据配售怪，而不是合作的部门，缺乏合作，以及恶劣的工作环境内的纠纷。


5 。否则了解criticalityof ，采样过程：

这是非常重要的是采取成立的时间（秒） ，样品在适当的持续时间（稳定性） ，以正确的数量和体积，参加适当的处理及储存样本，使用正确的设备和其他特殊考虑微生物检验的样品要求。


6 。未能适当培训人数incharge抽样：

这可能有重大影响的微生物采样的准确性。


7。不有效改变controlprogram ：

一旦完成验证过程，内部程序验证成果的影响，必须作相应的修改。经常观察到的沟通和跟进系统在某些时候失败，并影响不被修改的程序和活动。


8。不具有足够cleaningmonitoring ：

经常观察到的变化已经验证的系统，无论这些变化可能对整个系统的验证状态的影响。恒定的制造和验证部门之间的通信是至关重要的。


9。制造领域的失败toconsider内部的变化和程序批准的验证部门：

由于制造业在验证区域人员的技术知识缺乏，可能会忽略或不了解产生影响的重要的方面，从审查验证点。


10。工厂人员的失败primarilyfocused生产操作，要求符合程序cleaningvalidation 。

清歌一曲月如霜

Common Errors

1. Failing to perform a good process flow,beginning with the raw material sampling process and focusing on obviouslyimportant stages such as the compounding or filling process.

2. Failing to train operators well, andfailure to instill a sense of high commitment:

Most common mistakes, such as not following procedures, not taking samples at the time specified, improper handling of samples, not reporting discrepancies observed during the specific process executed, etc., undermine high quality performance and contribute to poor results. It is highly recommended to have representation from the validation department present throughout all runs.


3. Missing or inaccurate documentation:

In addition, to the common errors noted above in #2, a lack of documentation also causes difficult situations during future audits, because important key information will be missing during investigations. This is often the basis for general misunderstanding of data.


4. Lack of good coordination andcommunication between the different areas involved in the validation process:

Examples of poor coordination and communication include samples not being taken on time, required materials not being available, disputes within departments, lack of cooperation, and bad working environments based on placing blame rather than on cooperation.


5. Failing to understand the criticalityof the sampling process:

It is very important to take the samples at the time(s) established and for the proper durations (stability), taking correct quantities and volumes, attending to the proper handling and storage of samples, using the correct equipment, and other special considerations for samples requiring microbiological testing.


6. Failure to properly train persons incharge of sampling:

This can have a major impact on the accuracy of microbiological sampling.


7. Not having an effective change controlprogram:

Once the validation process is completed, internal procedures impacted by the validation outcomes must be revised accordingly. It is frequently observed that the communication and follow up systems fail at some point and impacted procedures and activities are not modified.


8. Not having an adequate cleaningmonitoring system:

It is frequently observed that changes are made to an already validated system, disregarding the impact those changes might have on the validation state of the total system. Constant communication between manufacturing and the validation department is critical.


9. Failure of manufacturing areas toconsider the validation department in internal changes and procedure approval:

Due to lack of technical knowledge in the validation area personnel in manufacturing might overlook or be unaware of important aspects that have impact from a validation point of review.


10. Failure of plant personnel primarilyfocused on the manufacturing operation, to require compliance with the cleaningvalidation procedures.

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