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1、类国洲际蜀亞艮公司 The AlliancePharm US丄LC.美国FDA认证与申办指南权威资讯系列工艺验证的通用原则指南GUIDELINE ON GENERAL PRINCIPLESOF PROCESS VALIDATION美国洲际药业有限公司网址：电子邮件:GUIDELINE ON GENERAL PRINCIPLESOF PROCESS VALIDATION工艺验证的通用原则指南Prepared by: Center for Drug Evaluation and Research,Center for Biologics Evaluation and Research, andCe
2、nter for Devices and Radiological HealthFood and Drug AdministrationMaintained by: Division of Manufacturing and Product Quality (HFD-320)Office of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, Maryland 20857Reprinted February, 1993byThe Div
3、ision of Field InvestigationsOffice of Regional OperationsOffice of Regulatory AffairsU.S.Food and Drug AdministrationTABLE OF CONTENTS 目录1. PURPOSE 目的II. SCOPE 范围III. INTRODUCTION 简介IV. GENERAL CONCEPTS 通用概念V. CGMP REGULATIONS FOR FINISHED PHARMACEUTICALS 关于最终药品的 CGMP 法规VI. GMP REGULATION FOR MEDIC
4、AL DEVICES 关于医疗器械的 CGMP 法规VII. PRELIMINARY CONSIDERATIONS 预先考虑VIII. ELEMENTS OF PROCESS VALIDATION 工艺验证的原理A. Prospective Validation 预确认1. Equipment and Process 设备和工艺a. Equipment : Installation Qualification 设备：安装确认b. Process: Performance Qualification 工艺：性能确认c. Product: Performance Qualification 产品：
5、性能确认2. System to Assure Timely Revalidation 保证及时再验证的系统3. Documentation 文件B. Retrospective Process Validation 回顾性工艺验证IX. ACCEPTABILITY OF PRODUCT TESTING 产品检验的可接受性Guideline on General Principles of Process Validation工艺验证通用原则指南I. PURPOSE 目的This guideline outlines general principles that FDA considers
6、to be acceptable elements of processvalidation for the preparation of human and animal drug products and medical devices.本指南概要描述了 FDA认为人用药、兽用药、医疗器械的工艺验证所必须遵循的一般原则。II. SCOPE 范围This guideline is issued under Section 10.90 (21 CFR 10.90) and is applicable to the manufacture of pharmaceuticals and medic
7、al devices. It states principles and practices of general applicability that are not legal requirements but are acceptable to the FDA. A person may rely upon this guideline with the assurance of its acceptability to FDA, or may follow different procedures. When different procedures are used, a perso
8、n may, but is not required to, discuss the matter in advance with FDA to prevent the expenditure of money and effort on activities that may later be determined to be unacceptable. In short, this guideline lists principles and practices which are acceptable to the FDA for the process validation of dr
9、ug products and medical devices; it does not list the principles and practices that must, in all instances, be used to comply with law.本指南是根据21 CFR 10.90章节出版的，适用于药品和医疗器械的生产。它所规定的通用适用 性的原则和实践虽不是法律要求，但是是被FDA所接受的。为确保FDA会接受，你可以依靠 本指南操作，也可依据不同的程序。当使用不同的程序时，你可以，但不是必须的，预先与 FDA 讨论这件事情避免在付出金钱和努力后做出来的成果FDA并不接
10、受。简言之，本指南列出了关 于药品和医疗器械工艺验证的FDA可接受的原则和实践，在任何情况下，都应按照法律要求进 行。III. INTRODUCTION 简介Process validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 2
11、1 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Several firms have asked FDA for specific guidance on what FDA expects firms to do to assure compliance with the requirements for process validation. This guideline discusses process validation el
12、ements and concepts that are considered by FDA as acceptable parts of a validation program.工艺验证是现行制剂药品生产质量管理规范规则(21 CFR210、211 )以及医疗器械生产质量管 理规范规则(21 CFR Part 820 )的要求，因此适用于药品和医疗器械的制造。许多企业向FDA 征询详细的指南，说明FDA期望企业做什么才能保证符合工艺验证的要求。许多企业向FDA 询问关于FDA期望企业做什么才能保证符合工艺验证的要求的特别指南。本指南论述了工艺验 证的原理和概念，是FDA认为是应该包括在验证
13、程序中的内容。The constituents of validation presented in this document are not intended to be all-inclusive. FDA recognizes that, because of the great variety of medical products (drug products and medical devices), processes and manufacturing facilities, it is not possible to state in one document all of
14、 the specific validation elements that are applicable. Several broad concepts, however, have general applicability which manufacturers can use successfully as a guide in validating a manufacturing process. Although the particular requirements of process validation will vary according to such factors
15、 as the nature of the medical product （e.g., sterile vs non-sterile） and the complexity of the process, the broad concepts stated in this document have general applicability and provide an acceptable framework for building a comprehensive approach to process validation.本文件描述的验证内容并不是包括所有的。FDA认为因为医疗产品
16、（药品和医疗器械）、工艺 和生产设施的多样性，在一个文件规定所有可适用的针对性验证要素是不可能的。本文件提供 了几个具有通用性用途的范围较宽的概念，生产企业可以成功的利用其作为对具体工艺验证的 指导。虽然工艺验证的具体要求随着医疗产品的性质（如，无菌与非无菌）和工艺的复杂程度 而不同，本文件中所阐述的范围较宽的通用性概念还是具有普遍适用性的并且为构建综合性的 工艺验证方法提供了合适的框架。Definitions定义Installation qualification - Establishing confidence that process equipment and ancillary systems are capable of consistently operating wit
