Hauck Walter W, Abernethy Darrell R, Williams Roger L
US Pharmacopeia, Documentary Standards Development, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, United States.
J Pharm Biomed Anal. 2008 Nov 4;48(3):1042-5. doi: 10.1016/j.jpba.2008.07.027. Epub 2008 Aug 9.
Decisions regarding acceptance criteria in regulatory or compendial contexts are among the most difficult to make. Acceptance criteria aid in the identification, on the one hand, of materials with unacceptable characteristics that should not pass the tests and procedures or, on the other hand, of unusual characteristics that indicate materials that are unlikely to pass the tests and procedures. For relatively complex procedures metrological approaches can differentiate between intra- and inter-laboratory variation and clarify unacceptable and unusual data. Such testing requires collaborative studies in which each participating laboratory essentially compares itself to the other laboratories in the collaborative study. Laboratories that use the reference standard established by the collaborative study are conducting a performance verification test in which they compare their capabilities to those of laboratories in the collaborative study. This paper considers aspects of a series of complex issues involving unacceptable/unusual characteristics primarily in the context of USP's work but with implications for manufacturing science via considerations of process capability and Quality by Design and to measurement science. Ultimately, acceptance criteria support the availability of good quality, safe, and effective medicines for patients and consumers.
在监管或药典环境中，关于验收标准的决策是最难做出的决策之一。验收标准一方面有助于识别具有不可接受特性、不应通过测试和程序的材料，另一方面有助于识别表明材料不太可能通过测试和程序的异常特性。对于相对复杂的程序，计量方法可以区分实验室内和实验室间的差异，并澄清不可接受和异常的数据。此类测试需要开展协作研究，在协作研究中，每个参与实验室本质上都是将自身与其他实验室进行比较。使用协作研究建立的参考标准的实验室正在进行性能验证测试，在此测试中，他们将自身能力与协作研究中的其他实验室的能力进行比较。本文主要在美国药典工作的背景下考虑了一系列涉及不可接受/异常特性的复杂问题的各个方面，但通过考虑过程能力、设计质量以及测量科学，这些问题对制药科学也有影响。最终，验收标准有助于为患者和消费者提供高质量、安全且有效的药品。
