变更控制：FDA对设备变更的新要求

20150128 ECA新闻：变更控制：FDA对设备变更的新要求  

2015-02-03 23:59:34|  分类： ECA新闻

GMP News

28/01/2015

Change Control: New FDA Expectations for Equipment Changes

变更控制：FDA对设备变更的新要求

The U.S. Food and Drug Administration (FDA) has published a new Manufacturing Equipment Addendum for the SUPAC Guidelines (Scale-up and post-approval changes), describing the administration's expectations when assessing manufacturing equipment changes.

美国FDA公布了新的生产设备备忘SUPAC指南（放大和批准后变更），其中描述了官方对生产设备变更时的评估要求。

This Guidance for Industry combines and supersedes the following Guidances:

该行业指南合并及取代了以下指南：

• SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
• SUPAC-IR/MR：即释和改释固体口服制剂，生产设备备忘
• SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum
• SUPAC-SS：非无菌半固体制剂，生产设备备忘
  

The biggest alteration was the removal of the lists of specific manufacturing equipment that were in both guidances. It now contains general information on SUPAC equipment. The reason is that FDA was concerned that misinterpretation of the lists could discourage advancements in manufacturing technologies.

最大的变化是删去了2份指南中的特定生产设备清单。它现在包括SUPAC设备的通用信息。删除的原因是FDA担心该清单会被误解，可能会对先进生产技术的应用造成障碍。

Furthermore, it clarifies the types of processes being referenced. The information in the document is presented in broad categories of unit operation. For each operation, equipment is categorized by class (operating principle) and subclass (design characteristic). Examples of types of equipment, but not specific brand information, are now given within the subclasses.

另外，它还澄清了所适用的工艺类型。文件中的信息给出了较为宽泛的单元操作类型。对每种操作，设备被分为大类（按操作原理）和子类（按设计属性）。设备类型的例子现在放在了子类中给出，但没有给出特定的品牌信息。

When assessing manufacturing equipment changes; FDA recommends to follow "a risk-based approach that includes a rationale and complies with the regulations, including the cGMP regulations". They also recommend "addressing the impact on the product quality attributes of equipment variations (via process parameters) when designing and developing the manufacturing process".

在对生产设备变更进行评估时，FDA推荐遵守“基于风险的方法，包括合理性，法规符合性，包括CGMP法规”。他们还推荐“在设计和开发生产工艺时，说明设备变更（通过工艺参数）对产品质量属性的影响”。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201513115934653/

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