工艺验证通用原则指南.docVIP

《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 PRINCIPLES OF PROCESS VALIDATION 美国洲际药业有限公司 网址： 电子邮件：ellen@AllianceP GUIDELINE ON GENERAL PRINCIPLES OF 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, and Center for Devices and Radiological Health Food and Drug Administration Maintained by: Division of Manufacturing and Product Quality (HFD-320) Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Reprinted February, 1993 by The Division of Field Investigations Office of Regional Operations Office of Regulatory Affairs U.S.Food and Drug Administration TABLE OF CONTENTS目录 I. 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 MEDICAL 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：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 to be acceptable elements of process validation 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 medical devices. It states principles and practices of general applicability that are not legal requirements but are acceptable to the FDA. A per