FDA行业指南中英对照待完成.docx

Document serial number【UU89WT-UU98YT-UU8CB-UUUT-UUT108】
FDA行业指南中英对照待完成
Guidance for Industry
Container Clument is intended to provide guidance on general principles for submitting information on packaging materials used for human drugs and biologics.
This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics , issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs. This guidance is not intended to describe the information that should be provided about packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。本文件替代了FDA在1987年2月发布的另一份指南，以及替代了仿制药办公室在1995年6月30日向行业内发布的包装政策声明信。本指南不描述药品的包装操作。
Approaches which differ from those described in this guidance may be followed, but the applicant is encouraged to discuss significant variations in advance with the appropriate CDER chemistry review staff or CBER review staff. This is to prevent applicants or sponsors from spending unnecessary time and effort in preparing a submission that the FDA may later determine to be unacceptable. 可以采取与本指南的内容不一致的措施，但是我们建议申请人就明显的差异预先与CDER或CBER的审核人员进行讨论。这样做的目的是为了避免申请人或发起人花费不必要的时间和努力准备申报资料，而这种申报资料经FDA认定是不可接受的。
II． BACKGROUND 背景
The Federal Food, Drug, and Cosmetic Act (the Act) mandates the need for adequate information related to packaging materials. Section 501(a)(3) of the Act states that a drug is deemed to be adulterated "if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health...." In addition, section 502 of the Act states that a drug is considered misbranded if there are packaging omissions. Also, section 505 of the Act requires a full description of the methods used in, and the facilities and controls used for, the packaging of drugs (see Attachment A). 联邦食品、药品和化妆品法案（简称“法案”）要求必须提供包装材料的充分信息。法案的第501(a)(3)部分