变更控制：FDA对设备变更提出新的期望

一沙一叶

                                                                          
                                                             变更控制：FDA对设备变更提出新的期望
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.

FDA最新颁布了一份新的生产设备附录用于SUPAC指南（放大和批准后变更），描述了监管者对于评估生产设备变更时的期望。

This Guidance for Industry combines and supersedes the following Guidances:

这份工艺指南联合并替代了以下指南：

l  SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum

SUPAC-IR/MR:速释和缓释的固体口服制剂，生产设备附录

l  SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum

SUPAC-SS:非无菌半固体制剂，生产设备附录。

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. Furthermore, it clarifies the types of processes being referenced.

最大的变化是去掉了两份指南中都有的特别生产设备清单。现在只包含SUPAC设备的一般信息。这样做的原因是FDA担心对于这份清单的错误解读可能会阻碍生产技术的进步。而且，它澄清了相关的工艺类型。

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. 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".

文件中的信息涉及到多种单元操作。每个单元操作中，设备都被根据操作原则分类、根据设计特定分为子类。当评估生产设备变化的时候，FDA建议遵循“基于风险的方法，要说明理由，并符合法规包括GMP法规的要求。”他们推荐“当设计和开发生产工艺的时候，要重点强调设备变化对产品质量属性的影响（通过工艺参数）”。


http://www.gmp-compliance.org/enews_04653_Change-Control-New-FDA-Expectations-for-Equipment-Changes.html

yuansoul

这就好像，你在说，论语不能用河南口音，要用山东口音才行。

kevinma520

谢谢分享。

syhorchid

谢谢分享

hirizon

很及时的分享，谢谢！