成人午夜又粗又硬又长_鲁一鲁AV2019在线_欧美深深色噜噜狠狠yyy_www.91色.com_色影音先锋av资源网_特级做A爰片久久毛片A片喷水_99精品无人区乱码1区2区3区_国产人妻久久精品一区_欧美午夜精品久久久久久浪潮_av免费无码天堂在线_蜜桃色欲AV久久无码精品软件_日美一级毛片_久久久久久久久性潮_国产乱对白精彩_日韩精品免费一区二区_亚洲欧美精品在线_无码国产69精品久久久久_开心五月综合激情综合五月_干一夜综合_亚洲中文有码字幕日本

9月1日，美國FDA發布一項有關亞硝胺雜質的指南，名為"人藥亞硝胺雜質的控制"。該指南介紹亞硝胺雜質引入的能條件，針對原料藥和制劑生產商應采取措施提出了建議，以檢測和防止亞硝胺雜質含量超出可接受水平。

對于本指南，FDA 表示，“最近在血管緊張素 II 受體阻滯劑、雷尼替丁、尼扎替丁、二甲雙胍、利福平和利福噴丁等藥物中，都發現了亞硝胺雜質，清楚地說明了執行風險管理策略的必要性，以識別和降低亞硝胺在藥品中存在風險” 。該指南是FDA有關硝胺雜質問題至今為止為詳細的一份文件，其建議適用于所有化學合成的API和含化學合成API的制劑。

該指南立即生效，反映了FDA認為亞硝胺雜質問題的緊迫性。

該指南共有24頁，正文分為五個部分，分別是：（1）介紹、（2）背景、（3）建議項、（4）維護藥物供應和（5）向FDA報告變更。

PharmLink指南組對正文主要內容進行翻譯，供大家參考。

I . INTRODUCTION 簡介
This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities. The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers (ARBs), ranitidine, nizatidine, and metformin, has made clear the need for a risk assessment strategy for potential nitrosamines in any pharmaceutical product at risk for their presence.

本指南建議原料藥和藥品生產商應采取的步驟，以檢測和防止藥品中亞硝胺雜質含量超標。該指南還介紹了可能引入亞硝胺雜質的條件。最近在血管緊張素II受體阻滯劑（ARB）、雷尼替丁、尼扎替丁和二甲雙胍等藥物中發現了可能是人類致癌物的亞硝胺雜質，這清楚地表明了，對于任何存在風險的藥品，進行潛在亞硝胺風險評估策略的必要性。

The discovery of nitrosamines in some types of drug products led FDA and other international regulators to conduct a detailed analysis of these impurities in affected APIs and drug products. Based on the Agency’s current understanding, this guidance discusses potential root causes of nitrosamine formation and advises API and drug product manufacturers that they should (1) conduct risk assessments of their approved or marketed products and products with pending applications, and (2) take appropriate actions to reduce or prevent the presence of nitrosamines in APIs and drug products.

在某些類型的藥物中，發現了亞硝胺，這些雜質對API和藥品的影響，導致FDA和其他國際監管機構對其進行了詳細分析。根據FDA的當前理解，本指南討論了亞硝胺形成的潛在根本原因，并告知原料藥和藥品生產商，他們應：

（1）對批準的或市售產品和待批準產品進行風險評估

（2）采取適當措施，減少或防止原料藥和藥品中亞硝胺的存在。

Although nitrosamine impurities have been found in only some drug products, and batches of those products have been recalled when there were unacceptable levels of these impurities, nitrosamine impurities might exist in other APIs and drug products due to use of vulnerable processes and materials that may produce nitrosamine impurities. Therefore, the recommendations made in this guidance apply to all chemically synthesized APIs. They also apply to drug products containing chemically synthesized APIs and to drug products at risk due to other factors described in this guidance (see sections II.B and C), and not just to the drug products that have been identified in FDA announcements.

盡管僅在某些藥品中發現了亞硝胺雜質，且當這些雜質的含量不可接受時，已召回了這些產品的批次，但由于脆弱的工藝和使用可能產生雜質的物質，其他原料藥和藥品中也可能存在亞硝胺雜質。因此，本指南中的建議適用于所有化學合成的API，還適用于含化學合成API的藥品，以及由于本指南中所述的其他因素而有風險的藥品（請參見II.B和C節），而不僅限于FDA公告中已確認的藥品。

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

通常，FDA的指南沒有確立法律上可執行的責任。相反，指南描述了FDA當前對某個主題的想法，除非引用了特定的監管或法規要求，否則僅應被視為建議。在FDA指南中使用“應”一詞的意思是建議或推薦某事，但不是必需的。