不用验证上下限。
首先，不现实。每个生产工艺有多个步骤，每个步骤也有多个参数，所有参数都在工艺验证（全规模上）进行上下限的验证，别说3批，30批可能都打不住。
其次，不符合现在工艺验证3个阶段的理念。操作参数范围及上下限的研究是在工艺验证的第1阶段：工艺设计中进行的；如无特殊情况，全规模的工艺验证（工艺性能确认）在操作参数的设定点上进行。
前面回答已经提供了国内的GMP问答，下面补充国外相关法规/指南的情况：
1. FDA： Process Validation: General Principles and Practices Guidance for Industry1 工艺验证 一般原则与规范
The approach to PPQ should be based on sound science and the manufacturer's overall level of product and process understanding and demonstrable control. The cumulative data from all relevant studies (e.g., designed experiments; laboratory, pilot, and commercial batches) should be used to establish the manufacturing conditions in the PPQ. To understand the commercial process sufficiently, the manufacturer will need to consider the effects of scale. However, it is not typically necessary to explore the entire operating range at commercial scale if assurance can be provided by process design data. Previous credible experience with sufficiently similar products and processes can also be helpful. In addition, we strongly recommend firms employ objective measures (e.g., statistical metrics) wherever feasible and meaningful to achieve adequate assurance.
工艺性能确认方法应该以可靠的科学、以及生产商对产品和工艺的理解和可验证的控制的总体水平为基础。来自所有相关研究的累积数据（例如，经过设计的实验、实验室小试、中试、以及商品批次）应用于在工艺性能确认中建立生产条件。为充分理解商业化工艺，生产商需考虑规模效应。不过，如果有工艺设计数据提供保证，通常不需要在商业化大规模生产探索整个运行范围。之前就有足够类似商品和工艺的可靠经验也有帮助。此外，只要是可行和对取得足够保证有意义，我们强烈建议公司使用客观测量方法（例如统计度量）。
2. EMA：Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission 生物技术来源活性物质生产的工艺验证以及在监管提交中所提供的数据
Process verification studies should confirm that the final manufacturing process (i.e. commercial scale process) performs effectively and is able to produce an active substance or intermediate of desired quality. Such studies are generally performed in accordance with normal set points for operating conditions and process parameters.
工艺确认研究应确认最终的生产工艺（即商业化规模工艺）能有效运行，且能够以生产预期质量的活性物质或中间体。为了对商业化工艺有足够的了解，生产企业需要考虑规模的效应。这些研究通常是在操作条件和工艺参数的正常设定点上进行的。
3. PDA TR60： Process Validation-A Lifecycle Approach 工艺验证-生命周期方法
PPQ studies are typically conducted in a manner that demonstrates a state of control under normal operating conditions to assess process variability expected during routine production. Process characterization (robustness) studies conducted during Stage 1 serve as the foundation for establishing normal operating ranges, proven acceptable ranges, and design space, if appropriate. Effects of scale should also be considered if scaled-down models are suitably qualified, well-planned, and executed. Study data on robustness should support conducting commercial-scale PPQ under routine manufacturing conditions. Supplemental engineering studies at scale may be appropriate to evaluate extremes of the normal operating range (e.g., line speed or compression speed). In most cases, available Stage 1 data make it unnecessary to execute PPQ over the entire operating range during the commercial manufacturing process. The process validation master plan should provide the justification for the approach used and reference all source data.
通常，PPQ 研究应证明在正常操作条件下的受控状态以评估日常生产期间可能的工艺变化性。第1阶段期间所开展的工艺特性（耐用性）研究可以作为建立正常操作范围、已证明的可接受的范围和设计空间的基础，如果适当。也应考虑规模效应，如果规模成比例缩小的模型经过适当地确认，良好计划并执行。耐用性研究数据应支持在日常生产条件下商业规模PPQ 的开展。适当规模的增补的工程研究对评估正常操作范围（例如线速度或压片速度）的极限可能是适当的。在绝大多数情况下，已有的第1 阶段数据使得在商业生产过程中没有必要在整个操作范围内执行PPQ。工艺验证主计划应提供所用方法的合理性证明并应用所有原始数据。
4. PDA-TR42：Process Validation of Protein Manufacturing 蛋白制生产的工艺验证
During the initial phase of process characterization, a list of critical and key operational parameters to be studied for each unit operation is confirmed. Following confirmation of parameters, detailed process characterization experiments can be designed to collect data for information only. Because the results of these experiments are used to characterize the process and define acceptable operational parameter ranges, pre-approved study acceptance criteria are not required. During full-scale process validation, operational parameters are held at their set points (targets), and performance parameters are monitored against pre-set numerical ranges as part of the protocol acceptance criteria.
在工艺表征的初始阶段，确定每个单元操作要研究的关键和重要操作参数的清单。在参数确认后，可以涉及详细的工艺表征实验来收集仅作为信息的数据。由于这些实验的结果用于表征工艺和定义可接受的操作参数范围，不需要预先批准的研究接受标准。在全规模工艺验证中，操作参数被置于其设定点（目标值），并根据预先设定的作为方案接受标准一部分的数值范围监测性能参数。
5. PDA TR60-3 Process Validation-A Lifecycle Approach，Annex 2 Biopharmaceutical Drug Substances Manufacturing 工艺验证-生命周期方法 附录2-生物药原液生产
PPQ lots usually focus on process performance run at the planned set-point of each operating parameter range. Since justification of the operating range for each operation may not be demonstrated during PPQ, the ranges should be justified using appropriate process-characterization studies (or technical rationale, where not possible) which, for practical reasons, are usually done using scale-down models.
PPQ批次通常聚焦于在每个操作参数范围计划的设定点上运行的工艺性能。由于每个操作的操作范围的依据可能不在PPQ期间证明，该范围应采用适当的工艺表征研究（或在不可能时，提供技术依据）论证，出于实际上的原因，这通常采用缩小规模模型来开展。
……
Concurrent full-scale studies are performed to confirm scaled-down lifetime studies and continue past PPQ runs. A concurrent lifetime validation protocol follows a set of predefined parameters during the course of manufacturing.
进行同步的全规模研究以确认缩小规模的（层析柱）寿命研究，并在PPQ后继续。同步的寿命验证方案遵循一套在生产过程中预先定义的参数。
工艺验证时不用做上下限，识林中已经讨论过该问题，可以参考：https://lib.shilinx.com/community.php/qa/thread/id/9080
不用验证上下限。
新修订药品GMP实施解答（二十二）
中国医药报 - 2013/03/13
4.问：药品的生产工艺参数往往是一个范围，在工艺验证时，是否对规定工艺参数的上限和下限分别进行验证，还是对上、下限条件进行分析，以最差条件进行验证？
答：《药品生产质量管理规范（2010年修订）》第一百三十八条规定：企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。确认或验证的范围和程度应当经过风险评估来确定。
在工艺设计阶段，企业就应当对关键参数进行确认，特别是那些直接影响产品质量的工艺参数，应当建立了可接受范围或限度。因而，药品生产阶段的工艺验证不同于研发期间的工艺研究，不是对工艺参数进行优化，而是证明能连续、稳定地按工艺条件生产出合格的产品。
“最差条件”这一概念，现在更多的出现在无菌相关验证过程中。进行无菌相关验证过程时，应当考虑影响无菌的因素的最差条件，在最差条件下进行验证，以证明无菌的措施或工艺是可行的。
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