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药品生产中计算机处理系统的验证指南
目录
I. INTRODUCTION 绪论
II.OVERVIEW 概述
III.HARDW ARE硬件
A. Types类型
1. Input Devices 输入设备
2. Output Devices 输出设备.
你与我之间3. Signal Converters 信号转换器
4. Central Processing Unit (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. Signal Conversion 信号转换
3. I/O Device Operation 输入/输出设备操作
4. Command 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 Identification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
VPUTERIZED OPERATIONS计算机化操作
A. Networks网络
B. Manual Back-up Systems手动备份系统
C. Input/Output Checks输入/输出检查
D. Process Documentation过程文件
E. Monitoring of Computerized Operations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 OF COMPUTERIZED SYSTEMS IN DRUG
PROCESSING
药品生产中计算机处理系统的验证指南
FEBRUARY, 1983
国家电网考试题库
National Center for Drugs and Biologics
and
Executive Director of Regional Operations
I. INTRODUCTION 绪论
Computers are being ud in increasing numbers in the pharmaceutical industry. As microprocessors become more powerful, reliable, and less expensive we can expect the proliferation of this technology, with increasing u 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 ud in a wide variety of ways in a pharmaceutical establishment, 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 the phas, either singly or as part 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 purpo of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments that utilize computer systems. This document is not intended to spell out how to conduct a CGMP drug inspection or t 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。
家是什么作文This guide discuss some potential problem areas in application of computer systems, provides inspectional guidance, and includes a glossary of terms the investigator should be aware of prior to performing the inspection。Questions and suggestions concerning this guide should be directed to the Manufacturing Standards and Industry Liaison Branch, Division of Drug Quality Compliance (HFN-323)，443-5307; or the Investigations and Engineering Branch，Division of Field Investigations (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 encountered in a drug establishment, it may be uful for inspectional purpos to begin with a broad overview of the system(s). Determine exactly what process 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 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 the general system loop (nsors, central processor, activator)。For example, the general system loop for a steam autoclave under computer control could consist of temperature/pressure nsors 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 tho computer controlled process that are most critical to drug product quality.。The are the systems which，of cour, merit clor inspection.
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。
玉米饽饽III. HARDWARE硬件
For each significant computerized system, it may be helpful to prepare or oed schematic drawing of t
he attendant hardware. The drawing need only include major input devices, output devices, signal converters, central processing unit, distribution systems, significant peripheral devices and how they are linked. Figure 1 is an example of such a drawing.
对于每一个重要的计算机处理系统，准备出专用的硬件示意图是非常有益的。这个图仅需要包括主要的输入设备，输出设备，信号转换器，中央处理单元，分配系统，重要的外围设备以及它们之间的联系。图1是这样一个图的例子。
Hardware Suppliers.硬件供应商
During the inspection identify the manufacturers/suppliers of important computer hardware，including the make and model designations where possible. Hardware to identify this way includes CPUs, disk/tape devices, CRTs, printers, and signal converters. Proper identification of hardware will enable further follow-up at computer vendors should that be needed.
在验证期间，识别重要的计算机硬件的制造商/供应商，包括每一可能部分的构造和模式。这种方式识别的硬件包括中央处理器（CPUs），磁盘/磁带设备，显示器（CRTs），打印机和信号转换器。严格的硬件验证将使进一步的继续验证，就需要计算机经销商协助。
A. Types类型
1. Input Devices. Equipment which translates external information into electrical puls which the computer can understand. Examples are thermocouples, flow meters, load cells, pH meters，pressure gauges, control panels, and operator keyboards.
输入设备。转换外部信息成为计算机能够理解的电子脉冲的装置。例如，热电偶，流量计，压力传感器，酸度计，压力表，控制面板，操作键盘。
Examples of functions are：功能举例：
袁文魁a) Thermocouple provides temperature input for calculation of F value in a sterilizer.
热电偶为消毒器中的F值的计算提供温度输入。
b) Flow meter provides volume of liquid component going into a mixing tank.
流量计提供加入一个混合罐的液体成分的体积。
c) Operator keyboard ud to enter autoclave load pattern number.
操作键盘被用来输入高压灭菌器运行模式号。
2. Output Devices. Equipment which receives electrical puls from the computer and either caus an action to occur, generally in controlling the manufacturing process, or passively records data. Examples are valves，switches, motors, solenoids, cathode ray tubes (CRTs), printers, and alarms.
输出设备。接收来自计算机的电子脉冲信号，并且触发一个动作产生。通常在控制制造过程或被动的记录数据。例如阀，开关，电动机，电磁铁，显示器(CRTs)，打印机和报警器。
Examples of functions are：功能举例：
a)Solenoid activates the impeller of a mixer.
苹果的好处圣诞快乐的英文电磁铁使一个搅拌器的叶轮活动
b)Valve controls the amount of steam delivered to a sterilizer.
阀控制释放到一个消毒器的蒸汽的数量。
c)Printer records significant events during sterilization process.
打印机记录杀菌过程期间的重要事件。
d) Alarm(buzzer, bell, light, etc.) sounds when temperature in a holding tank drops below desired temperature.
当一个储存罐的温度降到低于设定值时，报警器（蜂鸣器，铃，灯等）发出声音。
Most active output devices will be in proximity to the drug processing equipment under control, but not necessarily clo to the CPU. Passive output devices, however, may well be remote from the pro
cess or the CPU.
大部分有源输出设备都应邻近其控制下的药品生产设备，而不必靠近中央处理器（CPU）。然而，无源输出设备可以适当的远离生产过程或中央处理器（CPU）。
3. Signal Converters. Many input and output devices operate by issuing/receiving electrical signals that are in analog form. The analog signals must be converted to digital signals for u by the computer; converly, digital signals from the computer must be converted into analog signals for u by analog devices. To accomplish this, signal converter devices are ud.
信号转换器。众多输入和输出设备接收/发送模拟形式的电信号。为了让计算机使用这些模拟信号必须被转换成为数字信号；反之，来自计算机的数字信号必须被转换成为模拟信号才能被模拟设备使用。为了完成这些转换，就要用到信号转换器。
4. Central Processing Unit (CPU). This is the controller containing the logic circuitry of a computer system that conducts electronic switching. Logic circuits consist of three basic ctions - memory, arithmetic, and control.The CPU receives electrical puls from input devices and can nd electrical puls to output devices. It operates from input or memory instructions.
