Guidance for Industry
Non-Penicillin Beta-Lactam Drugs:
A cGMP Framework for Preventing Cross-Contamination
行业指南：预防非青霉素β-内酰胺类药物交叉
污染的cGMP框架
U.S. Department of Health and Human Services
美国卫生与公共服务部
Food and Drug Administrationthe spice girls
美国食品与药品监督管理局
Center for Drug Evaluation and Rearch (CDER)
药品评价和研究中心（CDER）
April 2013
2013.04
Current Good Manufacturing Practices (CGMPs)
现行质量管理规范（CGMPs）
告饶Guidance for Industryminio
Non-Penicillin Beta-Lactam Drugs:
A cGMP Framework for Preventing Cross-Contamination
行业指南：预防非青霉素β-内酰胺类药物交叉
污染的cGMP框架
urland
Additional copies are available from:
Office of Communications
googo
Division of Drug Information, WO51, Room 2201
Center for Drug Evaluation and Rearch
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Phone: 301-796-3400; Fax: 301-847-8714
myhobbydruginfo@v
v/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Rearch (CDER)
April 2013
Current Good Manufacturing Practices (CGMP)
TABLE OF CONTENTS 目录
I. INTRODUCTION简介 (4)
II. BACKGROUND背景 (6)
III. RECOMMENDATIONS建议 (13)
Guidance for Industry1
Non-Penicillin Beta-Lactam Drugs:
A CGMP Framework for Preventing Cross-Contamination中秋的习俗
行业指南：预防非青霉素β-内酰胺类药物交叉污染的CGMP框架
I. INTRODUCTION 简介
赫尔辛基英文
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.
本指南阐述了采取生产控制以预防制剂产品、原料药（APIs）与非青霉素β-内酰胺类药物发生交叉污染的重要性，并且提供了不同类别致敏性β-内酰胺类药物（包括青霉素类和非青霉素β-内酰胺类）发生交叉反应的可能性及其相对健康风险信息。最后，因为非青霉素β-内酰胺类药物发生交叉反应将导致健康风险，本指南声明其生产商一般应采用独立的设施进行生产。Drug cross-contamination is the contamination of one drug with one or more different drugs.
1This guidance was developed by the Office of Compliance, Office of Manufacturing and Product Quality, in the Center for Drug Evaluation and Rearch (CDER) at the Food and Drug Administration.
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 contro
l strategies to prevent cross-contamination, thereby reducing the potential for drug-induced, life-threatening allergic reactions.
药物交叉污染是指一种药物污染了另一种或多种其它药物。青霉素是一种可以引起很多人发生
过敏免疫反应的致敏成分，因此，青霉素生产时一个关键问题就是需要采用方法避免其它药物
被青霉素污染，另外CGMP法规也要求采用这些方法，具体见21 CFR §§ 211.42(d), 211.46(d), and 211.176。非青霉素β-内酰胺类药物也可能是致敏成分，其它药物被其污染后可能会引发类似青
霉素导致的超敏反应，包括可能会危及生命的过敏反应。因此，和青霉素一样，在生产非青霉
托福考试试题素β-内酰胺类药物时必须采取类似的控制策略避免交叉污染，从而减少药物引起危及生命的过
敏反应的可能性。beard的意思
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.
本指南的信息适用于原料药和制剂的生产商，包括再包装商。这些信息对于其他处理药物的机构，比如药房可能也会有用处。
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 statutory 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，并不确立法定责任。相反，指南文件描述的是当局对某一主题
目前的看法，除非引用了特定的法律法规要求，这份指南应当只被视为是对这些问题的建议。
