PDATR60中对⼯艺表征的描述
Process Characterization
⼯艺特征描述
乐观者Process characterization is a t of documented studies in which operational parameters are purpoly varied to determine their effect on product quality attributes and process performance. The approach us the knowledge and information from the risk asssments to determine a t of process characterization studies to examine propod ranges and interactions for process parameters. The resulting information is ud to define the PPQ ranges and acceptance criteria. It can also be ud to t the final parameter ranges and can be ud to develop a Design Space if using an enhanced approach, i.e., incorporating advanced analytical and/or manufacturing control technologies, to process development. Experiments can be designed to examine propod ranges and explore ones wider than tho that will normally be ud in operation. An element of process characterization may include multivariate designed experiments to define process design space. While univariate approaches are appropriate for some variables to establish a proven acceptable range (PAR), multivariate studies account for interactions between process parameters/material attributes (1).
⼯艺表征是⼀套⽂档证明的研究，在该研究中操作参数被故意改变以确定它们对产品质量属性和⼯艺性能的影响。该⽅法使⽤来⾃于风险评估的知识和信息以确定⼀套⼯艺表征研究来检验⼯艺参数推荐的范围及其交互作⽤。得到的信息被⽤于确定PPQ（⼯艺性能确认）范围和接受标准。如果是⽤⼀个加强的⽅法来开发⼯艺，它也能⽤于设置最终参数范围以及被⽤于开发⼀个设计空间，例如整合先进的分析和/或⽣产控制技术。实验可以被设计⽤来推荐的范围以及探索⼀些将⽤于正常运⾏更宽的范围。⼯艺表征的⼀个要素可能包括多变量设计实验以确定⼯艺设计空间。当单变量的⽅法适⽤于为⼀些变量去建⽴证明可接受的范围时（PAR），多变量研究可以对⼯艺参数/物料属性间的交互作⽤给出解释。
Since Studies designed to characterize the process and tting acceptable ranges for process parameters are usually performed at laboratory scale. The ability of laboratory-scale studies to predict process performance is desirable. When a laboratory scale model is ud in development, the adequacy of the
model should be verified and justified. When there are differences between actual and expected performance, laboratory models and model predictions should be appropriately modified. In that the conclusions drawn from the studies are applied directly to the commercial-scale process, qualification of
laboratory-scale models is esntial. Qualification of the scaled- down models should confirm that they perform in a manner that is reprentative of the full-scale process. This is shown by comparing operational parameters and inputs and outputs, including product quality attributes.
由于设计⽤来表征⼯艺和为⼯艺参数设置可接受范围的研究通常在实验室规模进⾏，因此实验室规模研究预测⼯艺性能的能⼒是值得期待的。当⼀个实验室规模的模型被⽤在研发中时，该模型的充分性应该被证实和合理说明。当在实际和期望的性能间有差异时，实验室模型和模型预测法应该适当纠正，因为从研究中得到的结论被直接应⽤到商业规模⼯艺。实验室模型的确认是必不可少的，缩⼩⽐例的模型的确认应该证实它们的性能代表实际的⽣产规模⼯艺，这通过⽐较运⾏参数和输⼊输出，包括产品质量属性。幼儿古诗词
Scaled-down models for chromatography steps for protein products can be qualified by performing multiple runs with input parameters at t points and comparing the results to the full-scale unit operation. Parameters evaluated should include tho that affect process consistency, such as step yields, elution profile, elution volume, and/or retention time. The should then be combined with tho that reprent product quality, such as pool purity and levels of process-related and host cell-related impurities.课题研究方法有哪些
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对⽤于蛋⽩产品的⾊谱层析步骤的缩⼩⽐例的模型能通过在设置点输⼊参数执⾏多次运⾏以及⽐较与实际规模的单元操作间的结果来确认。评价的参数应该包括那些影响⼯艺⼀致性，诸如⼯序收率、洗脱图、洗脱体积和/或保留时间，然后这些应该与那些代表产品质量诸如可怜的纯度和⼯艺有关的⽔平以及与宿主细胞有关的杂质结合起来。
Pilot-scale models of small molecules that are reprentative of the commercial manufacturing process may be ud for supportive PPQ data. In solid and liquid oral dosage forms, 10% of the commercial batch size and/or 100,000 units have been considered a reprentative scale (1). Scale-up effects for certain process, such as mixing freely soluble substances, tablet compression, or liquid filling may be well-known. Batch sizes at 10% of bulk size or run times of 100,000 dosage units provide a sufficient duration to determine a degree of control and process characterization, while uncovering any preliminary major problems. Full-scale confirmation/evaluation may be carried out when small-scale
uncovering any preliminary major problems. Full-scale confirmation/evaluation may be carried out when small-scale studies are ud to support PPQ.
代表商业⽣产⼯艺的⼩分⼦中试规模模型可能被⽤于⽀持PPQ数据，在固体和液体⼝服剂型，商业批
真诚待人量的10%和/或100000单位曾被考虑为⼀个代表性规模。某个⼯艺的放⼤的效果，诸如混合易溶解物质、药⽚压缩、或液体灌装可能众所周知。在原液10%的批量或运⾏100000剂量单位的倍数提供⼀个充分持续时间以确定控制程度和⼯艺特征，⽽未覆盖任何初步的主要问题。当⼩规模研究被⽤于⽀持PPQ时，实际规模确认/评估可能被执⾏。
历史上的皇帝For scale-down studies, the raw materials, component attributes, equipment, and process parameters should be comparable and indicative of the process intended for the commercial product.
对于缩⼩⽐例研究，其原料、组件属性、设备以及⼯艺参数应该是具可⽐性和能表明预期⽤于商业产品。
3.8 Product Characterization Testing Plan
产品表征测试计划
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未老先衰Some product characteristics may not be tested as part of the routine relea test panel. Examples of such product characteristics include residual DNA levels for biotechnology products (when DNA clearance has been established at a level that clearly exceeds safety requirements) or final product
porosity for solid oral dosage products (when dissolution testing is performed). In addition to relea specifications, Stage 1 deliverables should include other tests on the DS, DP, or critical intermediates that are needed in order to claim a comprehensive understanding of the product and process.
⼀些产品表征可能作为⽇常放⾏测试标准的⼀部分⽽不必测试，此类产品表征例⼦包括⽣物技术产品的残留DNA⽔平（当DNA清除率已经建⽴在⼀个能清晰超出安全要求的⽔平时）或固体⼝服制剂的最终产品的多孔性（当执⾏溶解度测试时），除了放⾏标准，阶段1可交付的成果应该包括其它对DS、DP或关键的中间体的测试为了说明对产品和⼯艺的全⾯理解。
