I. INTRODUCTION
绪论
This guidance outlines the general principles and approaches that FDA considers to be appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (API or drug substance), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use in validating a manufacturing process.
本指南列出了一些基本的准则和方法，FDA认为其是人用药和兽药以及生物产品，包括原料药（本指南里都称为药品或产品）生产的工艺验证的必要要素。本指南合并了所有制造商验证制造工艺可能会使用的准则和方法。
This guidance aligns process validation activities with the product lifecycle concept and with existing FDA guidance. The lifecycle concept links product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This guidance promotes modern manufacturing principles, process improvement, innovation, and sound science.
本指南用产品生命周期的概念以及已经存在的FDA指南对工艺验证措施进行调整。生命周期的概念接连了产品和工艺开发，商业化的制造工艺的确认，在常规销售生产中工艺维护于被控制的状态。 本指南推进了时兴的制造准则，工艺改进，创新和合理科学化。
The following categories of drugs are within the scope of this guidance:
下述类别的药品在本指南的范围中：
? Human drugs
? 人用药
? Veterinary drugs
? 兽药
? Biological and biotechnology products
? 生物的和生物技术产品
? Finished products and active pharmaceutical ingredients( API or drug substance)
? 成品和原料药
? The drug constituent of a combination (drug and medical device ) product
? 复方产品中的药物组分（药和医疗器械）
The following categories of products are not covered by this guidance:
如下类别的产品不在本指南的范围内
? Type A medicated articles and medicated feed
? 类别A含药产品和含药饲料
? Medical devices
? 含药装置
? Dietary supplements
? 食品添加剂
? Human tissues intended for transplantation regulated under section 361 of the Public Health Service Act
? 公众健康服务法案361章管理的移植用的人体组织
This guidance does not specify what information should be included as part of a regulatory submission. Interested persons can refer to the appropriate guidance or contact the appropriate Center in determining what information should be included in a submission.
本指南并不具体应包含什么信息，以作为法规递交的部分内容。感兴趣的人员可以参阅适当的指南或联系适当的中心（FDA机构）以确定什么信息应包含在申请中。
This guidance also does not specifically discuss the validation of automated process control systems (i.e., computer hardware and software interfaces), which are commonly integrated into modern drug manufacturing equipment. This guidance is relevant, however, to the validation of the processes that include automated equipment in processing.
本指南也不具体讨论自动工艺控制系统（如计算机硬件和软件界面）的验证， 这些常并入到时兴的药品制造设备中。然而，本指南和运行中自动设备工艺的验证相关。
FDA’s guidance documents, including this guidance, 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.
FDA指南文件，包括本指南，并不制定法律上的强制性的职责。这些指南叙述了FDA对此话题当前的看法，仅该被当作是建议，除非其被特定的法令要求所引用。 FDA指南中使用的词word表明建议了某些东西但不是必须的。
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