工业指南
非青霉素β-内酰胺类药品防止交叉污染的指导原则
动漫美少女图片I. 简介
II. 背景
III. 七夕短句建议
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You can u an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
本指南代表当前FDA对本议题的看法。本指南并不授予任何人任何特权，也不对FDA或公众起任何约束作用。如果有替代的方法能满足法律法规的要求，则可以使用该替代方法。如果想要讨论替代方法，请与FDA负责实施该指南的工作人员联系。如果不能与指定的合适FDA工作人员联系，请拨打该指南标题页列出的电话号码。
I. INTRODUCTION
I. 简介
This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the class of nsitizing beta-lactams (including both penicillins and non-penicillin beta-lactams). Finally, this guidance clarifies that manufacturers generally should utilize parate facilities for the manufacture of non-penicillin beta-lactams becau tho compounds po health risks associated with cross-reactivity.
本指南描述了对非青霉素β-内酰胺类成品和原料药的生产过程进行控制，以防止交叉污染的重要性。本指南也提供了有关不同类别致敏性β-内酰胺类药品（包括青霉素类和非青霉素类）发生交叉反应的可能性及其相对健康风险信息。最后，本指南阐明生产商通常应利用单独的生产设备来生产非青霉素β-内酰胺类药品，因为此类化合物会对健康造成交叉反
应的风险。
Drug cross-contamination is the contamination of one drug with one or more different drugs. Penicillin can be a nsitizing agent that triggers a hypernsitive exaggerated allergic immune respon in some people. Accordingly, implementing methods for preventing cross-contamination of other drugs with penicillin is a key element of manufacturing penicillin and current good manufacturing practice (CGMP) regulations require the u of such methods. See, e.g., 21 CFR §§ 211.42(d), 211.46(d), and 211.176. Non-penicillin beta-lactam drugs also may be nsitizing agents and cross-contamination with non-penicillin beta-lactam drugs can initiate the same types of drug-induced hypernsitivity reactions that penicillins can trigger, including life-threatening allergic reactions. Therefore, manufacturers of non-penicillin beta-lactam drugs should employ similar control strategies to prevent cross-contamination, thereby reducing the potential for drug-induced, life-threatening allergic reactions.
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药品交叉污染指一种药品对另一种或其他多种药品造成的污染。青霉素是一种会引起一些
人发生过激过敏免疫反应的敏化剂。因此，生产青霉素类药物时采取措施以防止其他药品与青霉素间的交叉污染是一个关键因素，现行药品生产管理规范也要求实施此类措施，见21 CFR §§ 211.42(d), 211.46(d), 以及 211.176。非青霉素β-内酰胺类药品也可能是敏化剂，被其污染可能会引起造成与青霉素类药物相同的超敏反应，包括可能危及生命的过敏反应。因此，非青霉素β-内酰胺类药品的生产商应采取类似的控制措施以防止交叉污染，减少药品引起的危及生命的过敏反应的可能性。
The information in this guidance is intended for manufacturers of finished pharmaceuticals and APIs, including repackagers. Other establishments that handle drugs, such as pharmacy compounders, may find this information uful.
本指南的信息主要用于成品和原料药的生产商，包括再包装商。对其他药物处理机构，如药物配制商等也有用处。
番泻
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statut
ory requirements are cited. The u of the word should in FDA guidance means that something is suggested or recommended, but not required.
FDA的指南文件，包括本指南，无法律责任约束力。指南文件描述的是FDA现在对某一问题的看法，应被视为对这些问题的建议，除非指南文件参考了特定法律法规的要求。FDA指南中should一词表示要求，只是建议或意见，并非强制要求。
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II. BACKGROUND
II. 背景
A. Regulatory Framework
刘笑寒
A. 法规框架
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) requires that, with few exceptions, all drugs be manufactured in compliance with current good manufacturing practices (CGMPs). Drugs that are not in compliance with C
GMPs are considered to be adulterated. Furthermore, finished pharmaceuticals are required to comply with the CGMP regulations at 21 CFR parts 210 and 211.
联邦食品药品和化妆品法案(21 U.S.C. 351(a)(2)(B))中501(a)(2)(B)部分要求：除少数例外情况外，所有药品生产都应符合现行药品生产质量管理规范(CGMPs)。不符合该要求的将被视为假药。此外，成品药应符合联邦法规第21章中第210和211部分对CGMP方面的要求。
Several CGMP regulations directly address facility and equipment controls and cleaning. For example, § 211.42(c) requires building and facility controls in general to prevent cross-contamination of drug products. Specifically, the regulation states, “[t]here shall be parate or defined areas or such other control systems for the firm’s operations as are necessary to prevent contamination or mix-ups” during manufacturing, processing, packaging, storage, and holding.
一些CGMP法规对设施和设备的控制和清洁有直接规定。比如§ 211.42(c)要求对建筑物和设施应进行控制，以防止药品的交叉污染。该法规尤其指出，在生产、加工、包装、储存
和处理过程中，“应有独立或特定的区域或其他类似控制系统来防止污染或混淆”
With respect to penicillin, § 211.42(d) requires that “[o]perations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities parate from tho ud for other drug products for human u.” However, FDA has clarified that parate buildings may not be necessary, provided that the ction of the manufacturing facility dedicated to manufacturing penicillin is isolated (i.e., completely and comprehensively parated) from the areas of the facility in which non-penicillin products are manufactured.2 Under § 211.46(d), manufacturers must completely parate air handling systems for penicillin from tho ud for other drugs for human u. Additionally, § 211.176 requires manufacturers to test non-penicillin drug products for penicillin where the possibility of exposure to cross-contamination exists, and prohibits manufacturers from marketing such products if detectable levels of penicillin are found.
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