翻译完稿 GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONT(13)

再一次,回顾原始实验数据和测试的结果，多方面分析确定实际数据是否匹配现场记录。

Evaluate the raw data used to generate the data filed documenting that the method is stability indicating and the level of impurities.

评估原始数据用于生成数据记录文件,包括稳定性要求和杂质的水平。 ------------------------------------------------------------------蓝志明 20. COMPUTERIZED LABORATORY DATA ACQUISITION SYSTEMS

实验室计算机数据采集系统

The use of computerized laboratory data acquisition systems is not new and is addressed in the following CGMP guidance documents: 实验室计算机数据采集系统的使用并不是新的规定,在以下的CGMP指南文件中有规定：

Compliance Policy Guide 7132a.07 Computerized Drug Processing: Input/Output Checking.

符合政策指南7132a.07《计算机化药物加工：输入/输出检查》 Compliance Policy Guide 7132a.08 Computerized Drug Processing: Identification of \符合政策指南7132a.08《计算机化药物加工：批量生产和记录控制中人的作用的识别》

Compliance Policy Guide 7132a.11 Computerized Drug Processing: CGMP Applicability to Hardware and Software

符合政策指南7132a.11《计算机化药物加工：硬件和软件的CGMP适用性》

Compliance Policy Guide 7132a.12 Computerized Drug Processing: Vendor Responsibility

符合政策指南7132a.12《计算机化药物加工：供应商职责》

Compliance Policy Guide 7132a.15 Computerized Drug Processing: Source Code for Process Control Application Programs

符合政策指南7132a.15《计算机化药物加工：过程控制应用程序的源代码》

Guide to Inspection of Computerized Systems in Drug Processing.

药物生产过程中计算机系统检查指南

It is important, for computerized and non computerized systems, to define the universe of data that will be collected, the procedures to collect it, and the means to verify its accuracy. Equally important are the procedure to audit data and programs and the process for correcting errors. Several issues must be addressed when evaluating computerized laboratory systems. These include data collection, processing, data integrity, and security.

对于计算机化系统和非计算机化系统来说，规定数据的收集、过程及验证其准确性的方法，是很重要的。数据和程序审计，纠正错误的程序也是同等重要的。在评估实验室计算机系统时，应包含以下几个方面：数据的收集、处理、完整性、安全性。

Procedures should only be judged adequate when data are secure, raw data are not accidentally lost, and data cannot be tampered with. The system must assure that raw data are stored and actually processed.

当数据安全时仅评价程序是否充分，原始数据不可丢失，数据不可更改。系统必须确保原始数据的储存和实际处理。

The agency has provided some basic guidance on security and authenticity issues for computerized systems:

FDA为计算机系统安全性和真实性提供了基本指南。

Provision must be made so that only authorized individuals can make data entries.

应规定，只有授权人员才可以进行数据输入。

Data entries may not be deleted. Changes must be made in the form of amendments.

输入数据不可以删除，应以修订的形式进行更改。 The data base must be made as tamperproof as possible. 应尽可能的防止篡改数据库。

The Standard Operating Procedures must describe the procedures for ensuring the validity of the data.

标准操作规程应规定确保数据有效性的程序。

One basic aspect of validation of laboratory computerized data acquisition requires a comparison of data from the specific instrument with that same data electronically transmitted through the system and emanating on a printer. Periodic data comparisons would be sufficient only when such comparisons have been made over a sufficient period of time to assure that the computerized system produces consistent and valid results.

实验室计算机数据获得的验证的一个基本方面是，要求从特定仪器获得的数据和通过系统电子传送或打印出来的数据进行对比。周期性数据对比需充分，当这种对比在足够长的时间里可以确认计算机系统产生稳定和有效的数据，

21. LABORATORY MANAGEMENT 实验室管理

Overall management of the laboratory work, its staff, and the evaluation of the results of analysis are important elements in the evaluation of a control laboratory.

在控制实验室评估中，实验室工作和人员的全面管理以及分析结果的评估都是很重要的因素。

Span of supervisory control, personnel qualifications, turnover of analysts, and scope of the laboratory's responsibility are important issues to examine when determining the quality of overall management and supervision of work.

管理控制的范围、人员资格的确认、检验员的流动性、实验室职责的范围，在确认全面管理和监督工作质量时都是重点检查项目。 Individually or collectively, these factors are the basis for an objection only when they are shown to result in inadequate performance of responsibilities required by the CGMPs.

仅当结果显示未充分执行CGMPs要求的职责时，单个或全面的因素才能成为缺陷的依据。

Review laboratory logs for the sequence of analysis and the sequence of manufacturing dates. Examine laboratory records and logs for vital information about the technical competence of the staff and the quality control procedures used in the laboratory.

按生产日期顺序和检验顺序进行实验室日志的审核。检查有关于人员技术技能和实验室质量控制程序重要信息实验室记录和日志。

Observe analysts performing the operations described in the application. There is no substitute for actually seeing the work performed and noting whether good technique is used. You should not stand over the analysts, but watch from a distance and evaluate their actions.

在申请中描述观察到的检验员的操作。没有什么可以取代真实看到的工作过程和技术是否良好。你不应监督检验员,但可远距离的观察并评估他们的行动。

Sometimes the company's employees have insufficient training or time to recognize situations that require further investigation and explanation.

有时，公司的人员没有受到足够的培训或没有足够时间进行更近一步的调查和解释。

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