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1、药品生产中计算机处理系统的验证指南目录I. INTRODUCTION 绪论 .OVERVIEW概述III. HARDW ARE 硬件A. Types 类型1. Input Devices 输入设备2. Output Devices 输岀设备.3. Signal Converters 信号转换器4. Cen tral Processi ng Uni t (CPU) 中央处理单元5. Distribution System 分布式系统6. Peripheral Devices 外围设备B. Key Points 关键点1. Location 位置2. Sig nal Con version 信号转
2、换3. I/O Device Operation输入/输岀设备操作4. Comma nd Over-rides 指令中断5. Maintenance 维护C. Validation of Hardware 硬件确认IV. SOFTWARE 软件A. Levels 分级B. Software Ide ntificatio n 软件验证C. Key Points 关键点1. Software Development 软件升级2. Software Security 软件安全D. Validation of Software 软件确认 COMPUTERIZED OPERATIONS计算机化操作A.
3、Networks 网络B. Manual Back-up Systems 手动备份系统C. I nput/Output Checks 输入 / 输岀检查D. Process Documentation 过程文件E. Mon itori ng of Computerized Operatio ns 计算机化操作的监视F. Alarms 报警G. Shutdown Recovery 停止恢复VI . CGMP GUIDANCE CGMP 指导A. Hardware 硬件B. Software 软件附录：GLOSSARY术语表GUIDE TO INSPECTION OFCOMPUTERIZED SY
4、STEMS IN DRUGPROCESSING药品生产中计算机处理系统的验证指南FEBRUARY, 1983National Center for Drugs and BiologicsandExecutive Director of Regional OperationsI. INTRODUCTION 绪论Computers are being used in increasing numbers in the pharmaceutical industry. As microprocessors become more powerful, reliable, and less expens
5、ive we can expect the proliferation of this technology, with increasing use by even very small pharmaceutical establishments.在制药工业中，越来越多数量的计算机被使用。随着微处理器功能越来越 强大，性能越来越 稳定和价格 越来越便宜我们可以期待这个技 术被更广泛应 用，甚至越来越多的被用在 非常小的制药设备。Computer systems are used in a wide variety of ways in a pharmaceutical establishme
6、nt, such as, maintenance of quarantine systems for drug components, control of significant steps in manufacturing the dosage form, control of laboratory functions, management of warehousing and distribution activities. Computer systems may control one or more of these phases, either singly or as par
7、t of a highly automated integrated complex. 计算机系统 以多种多样的方式被用在制药设备中。 例如，药品成分检疫系统的维 持，制剂过程中 重要步 骤的控制，实验室功能的控制，仓库和销售情况 的管理。计算机系统 可以控制这些阶段 的一个或多个， 单独的或高自动化的完整的系统的 一部分。The purpose of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments
8、that utilize computer systems. This document is not intended to spell out how to conduct a CGMP drug inspection or set forth reporting requirements, but rather what aspects of computerized systems to address during such inspections and suggestions on how to address the systems. 这个指南的目的是为了给这个领域 的审查者提
9、供一个应 用计算机系统的制药设 施的验证 框架。这个文件 不是侧重于清楚说明怎样进行一个 CGMP 药品验证，也不是阐明申 报报告要求，而是说明 计算机处理 系统的哪些方面需要 在验证过程中验证 和怎样 对系统进行验证的 建议。This guide discusses some potential problem areas in application of computer systems, provides inspectional guidance, and includes a glossary of terms the investigator should be aware of
10、 prior to performing theinspection 。 Questions and suggestions concerning thisguide should be directed to the Manufacturing Standards and Industry Liaison Branch, Division of Drug Quality Compliance (HFN-323)， 443-5307; or the Investigations andEngineering Branch ， Division of Field Investigations (
11、HFO-520), 443-3276. 这个指南论述了计算机系统 应用中的一些潜在的问题，提供验证的指 导，并包含审查者在进行验证前应 该知道的术语表。 和这个指南相关联的问题和建议来自制造标准和生产联络部门，药品质量管理(HFN-323 ) , 443-5307；或研究和工程部门，Division of Field Investigations (HFO-520),443-3276 。II. OVERVIEW 概述When a computer system is first encounteredin a drug establishment, it may be usefulfor in
12、spectional purposes to begin with a broad overview of the system(s). Determine exactly what processes and functions are under computer control or monitoring and which are not. Computer involvement may be much more limited than it may initially appear。For example, computer application may be limited
13、to control of a sterilization cycle in a single autoclave, or maintenance of distribution records.当一个计算机系统 第一次在药品设备被遇到，从验证的目的 说从系统的整体开始入手是有用的。严密地 确定什么过程和功能在计算机 控制或监视下，哪些没有。计算机牵连可能越来越多被 限制比它最初被看 起来。例如，计算机 应用可能是有限的在对单独的高压灭菌器内的一个灭菌周期的控制，或销售 记录的 保管。For each drug process under computer control determine
14、the general system loop(sensors, central processor, activator)。For example, the general system loop for a steamautoclave under computer control could consist of temperature/pressure sensors connected to a microprocessor that transmits commands to steam/vacuum control valves.对计算机控制下的每一个药品生产过程， 确定通常的系
15、统环路(传感 器，中央处理器， 执行器)。例如， 计算机控制下的一个蒸汽高压灭菌器的通常的系统环路由连接到 微处理器的 温度/压力传感器组成，这 个微处理器发送控制命令到蒸汽/ 真空控制阀。The overview should enable the investigator to identify those computer controlled processes that are most critical to drug product quality.。 These are the systems which ，of course, merit closer inspection.
16、这个概述应该使审查者能够确定那些对药品生产质量最关键性的计算机控制过程。 当然，这些是更 有益 于验证的方法。III. HARDWARE 硬件For each significant computerized system, it may be helpful to prepare or oed schematic drawing of the attendant hardware. The drawing need only include major input devices, output devices, signal converters, central processing unit, distribution systems, significant periphera
