04.10.2017
The Role of Visual Inspection in the Release ofParenterals
注射剂放行中目视检查的作用
According to the requirements of pharmacopoeias (e.g.EU or US), batches of sterile injectables must be 100% visually inspected.This test, which is to be rated as an in-process control, must be validated;because of its probabilistic nature. However, it is not 100% free from errors.That means that the discovery of defects like particles, for example, is aquestion of probability. Visual inspection cannot rule out the presence ofdefects in a tested batch. The higher one raises the probability of detection,the higher the so-called False Reject Rate goes, meaning the rejection ofactually error-free test pieces.
根据药典（例如欧洲药典和美国药典）的要求，无菌注射剂批次必须经过100%目视检查。鉴于目视检查的或然性，此检查归类为中控检查，必须经过验证。但是，这并不表示100%无误，也就是说检出如颗粒物是有一定概率的。目视检查并不能排除受测批次中仍存在缺陷。检出的概率越高，则所谓的错误拒收率就会越高，竟未着实际无误测试件拒收越多。
Now, how is one to handle the fact that the result ofan officially required batch test might not be 100% correct?
那么要如何处理这种官方要求的检测可能并不能得到100%正确结果的情况呢？
For this, the US Pharmacopoeia intended an additionalsampling inspection of containers which were found to be adequate in chapter<790>. After much delay (because of US-internal discussions), the additional chapter <1790> was publishednow, too. Intended are so-called AQL tests (acceptable quality limit).Depending on the number of containers in a batch, a dictated AQL table definesthe size of the sample, which is then visually inspected and in which only afixed number of defects may be found. The number thereby depends on thecriticality of the defect. The number of permitted critical defects in an AQLtest should be 0, numbers permitted for major and minor defects are alsospecified by the AQL limit. The USP set that limit at 0.65. This has the greatadvantage of making the pharmacopoeia requirement measurable that batches ofparenterals must be practically or essentially free of particles.
对此，美国药典认为应于对容器进行更多的取样检查，而不仅局限于<790>认为足够的内容。在拖了很久之后（因为美国内部讨论），现在<1790>也已经发布了，其内容是所谓的AQL测试（可接受质量限度）。依据一个批次中容器数量的不同，有一个专门的AQL表格规定了样本数，这些数量的样本会进行目视检查，所允许发现的缺陷数量有规定。该数量取决于缺陷的关键程度。在一个AQL测试中所允许的关键缺陷数量应为0，允许的主要缺陷和轻微缺陷数量也由AQL限度规定了。USP设定的限度为0.65。这有一个很大的优点就是让药典要求变得可测量，注射剂的批次必须实际或基本上没有颗粒物。
The European Pharmacopoeia does not include arequirement about AQL testing, so far. Still, AQL testing is considered GoodIndustry Practice in Europe, as well, and is performed by many pharmaceuticalcompanies. After all, GMP inspectors are also aware that a 100% (in-process)control is not absolutely free from errors. 截止目前，欧洲药典中尚没有关于AQL测试的要求。AQL测试在欧洲仍被认为是优良行业规范，许多制药企业都在使用。毕竟GMP检查人员也明白执行100%（中控）检查并不能保证绝对无错误发生。
On the other hand, the AQL testing may not be misused,either. Companies could release batches with known defects as long as they passthe AQL testing. Measures to investigate the defects and prevent them in thefuture wouldn't have to be taken, either. This does not correspond with theidea of quality in the pharmaceutical industry. This issue, however, is one ofthe reasons why the additional USP chapter <1790> has been published withso great a delay and only after the revision of some clarifying passages.
另一方面，AQL测试也不太可能被误用。只要能通过AQL测试，公司可能还是会放行已知有缺陷的批次，并且不对缺陷进行调查防止其在未来重复发生，这与制药行业中质量理念是背道而驰的，而这个问题也是为什么USP在研究很久并且修订了一些澄清内容段落之后才发布<1790>的原因之一。
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发表于 2017-10-11 22:25:36
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这么好的资料，值得拥有