这句话如何理解呢？？？

beiwei5du

Figure 3 is a simple but effective example of how this can be implemented in practice. There is nothing fundamentally new here, except for the fact that the Guidance introduces some alternative terminology, and that the proposed framework is depicted pictorially.The approach can be summarized as follows:
• The purpose of a unit operation is to deliver or protect some aspect(s) of the target product profile (also known as attributes at risk).
• The identification and management of significant variables constitutes the control strategy for the unit operation.
• Significant variables can entail equipment monitoring (EM), material analysis (MA), or quality control (QC) testing.
• Process analytical technology (PAT) is treated as a means to an end, rather than a variable per se, within the framework. PAT does not replace required in-process testing and finished product release testing, although it can provide realtime data for use in such cGMP tests.（这句话如何理解呢？？哪位大神指教一下，非常感谢）
• The compilation of control strategy commitments can be prospective or retrospective (new versus legacy products), and be based on a combination of manufacturing experience, technical literature, quality by design, risk analysis, etc.



选自<FDA 2011 Process Validation Guidance: Process Validation Revisited>
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm334560.pdf

河西智叟

beiwei5du 发表于 2016-10-7 11:49
&quot;is treated as a means to an end, rather than a variable per se, within the framework&quot;到底如何理解 ...

我的理解就是不能因为有了过程分析所需的参数，某些特定的品种还是需要做中间体分析和成品分析

肖丽（Lily）

过程分析技术（PAT）视为达到目的的一种手段，而不是一个变量本身在框架内。PAT不能替代中控检测和成品放行检测，虽然它可以为cGMP检测提供实时的数据。

肖丽（Lily）

肖丽（Lily） 发表于 2016-10-7 08:27
过程分析技术（PAT）视为达到目的的一种手段，而不是一个变量本身在框架内。PAT不能替代中控检测和成品放行 ...

新手路过，不喜勿喷

河西智叟

如果确实需要进行的中间检测，或者最终的成品检验，不能因为中间的过程监控可以提供实时数据，而被取代

xqliu

PAT数据可以为中控和成品检验提供参考和支持，但不能等同。

beiwei5du

河西智叟 发表于 2016-10-7 09:31
如果确实需要进行的中间检测，或者最终的成品检验，不能因为中间的过程监控可以提供实时数据，而被取代

"is treated as a means to an end, rather than a variable per se, within the framework"到底如何理解？？是指PAT只是终点指示手段？？而本身不是一个可变量？？比如一般的PAT方式只是表示是否到达或是没有达到（半定量判定？？），决策是否执行后续操作。但无法指示具体的数据，从而体现数据的变异性？？？

cnosema

beiwei5du 发表于 2016-10-7 11:49
&quot;is treated as a means to an end, rather than a variable per se, within the framework&quot;到底如何理解 ...

但是PAT很多是实时在线的检测数据呀，比如吸光度，pH等等

lgnllhp

观点和8楼类似，就是虽然有些设备有了在线检测功能，这个检测功能可以作为配制等的终点判定，但是离线的取样检测还是需要进行的

BOBO1899

PAT:
a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.

PAT是生产过程中关键物料、工艺控制的一种手段，使产品整个过程都处于可控状态。目的是为最终产品质量提供保证与支持。产品的放行不能只看最终检测结果（结果合格并不能代表产品可以放行），而是要从整个过程来考虑。