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发表于 2014-6-10 11:55:45
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cgc717 发表于 2014-6-9 21:45 
谢谢！
一个产品有那么多的质量属性，其中有些质量属性于不管你怎么去生产，它总是合格的；而有些质量 ...
呵呵，这个真是有点说不清楚啊，毕竟没有从事过相应的工作。估计需要好好学习一下ICH Q8 Q9 Q10吧。翻了一下Q8，里面对CQAs 有如下描述，参考一下吧。
2.2 Critical Quality Attributes
A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates (in-process materials) and drug product. CQAs of solid oral dosage forms are typically those spects affecting product purity, strength, drug release and stability. CQAs for other delivery systems can additionally include more product specific aspects, such as aerodynamic properties for inhaled products, sterility for parenterals, and adhesion properties for transdermal atches. For drug substances, raw materials and intermediates, the CQAs can additionally
include those properties (e.g., particle size distribution, bulk density) that affect drug
product CQAs. Potential drug product CQAs derived from the quality target product profile and/or prior knowledge are used to guide the product and process development. The list of
potential CQAs can be modified when the formulation and manufacturing process are selected and as product knowledge and process understanding increase. Quality risk management can be used to prioritize the list of potential CQAs for subsequent evaluation. Relevant CQAs can be identified by an iterative process of quality risk management and experimentation that assesses the extent to which their variation can have an impact on the quality of the drug product.
2.3 Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs
Risk assessment is a valuable science-based process used in quality risk management (see ICH Q9) that can aid in identifying which material attributes and process parameters potentially have an effect on product CQAs. Risk assessment is typically performed early in the pharmaceutical development process and is repeated as more information becomes available and greater knowledge is obtained. Risk assessment tools can be used to identify and rank parameters (e.g., process, equipment, input materials) with potential to have an impact on product quality, based on prior knowledge and initial experimental data. For an illustrative example,see Appendix 2. The initial list of potential parameters can be quite extensive, but can be modified and prioritized by further studies (e.g., through a combination of design of
experiments, mechanistic models). The list can be refined further through experimentation to determine the significance of individual variables and potential interactions. Once the significant parameters are identified, they can be further studied (e.g., through a combination of design of experiments, mathematical models, or studies that lead to mechanistic nderstanding) to achieve a higher level of process understanding. |
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