英文版指南(生产自动化管理规范)

生产自动化管理规范......

Technical Document Review: Good Automated Manufacturing Practice (GAMP) Guide for the Validation of Automated SystemIntroduction This document aims to review the Good Automated Manufacturing Practice Guide for the Validation of Automated System (GAMP 4), December 2001, published by the ISPE. To learn more about GAMP or to place an order, visit http://doc.guandang.net The content of this summary hopes to identify the top level requirements of the steps undertaken to validate an automated manufacturing process, this includes environmental monitoring systems, autoclaves, filling lines, and any other process governed by electronic control rather than a manual process. In the late eighties and early nineties the validation of automated system in pharmaceutical manufacturing assumed a much greater importance than had previously been the case. Although regulatory guidelines concerning the use of such automated systems had been available for some time, the systems had been subject to less regulatory scrutiny than other areas of production and were deemed to be less mature than more conventional areas. An industry group was set up to promote the understanding of the industry requirements. That group was made up of several major pharmaceutical manufacturers and become the GAMP Forum. In 2000, GAMP became formally affiliated with ISPE as a technical sub-committee within the organization.

GAMP 1.0 Mar 1995

GAMP 2.0 Mar 1996

GAMP 3.0 Mar 1998

GAMP 4.0 Mar 2001

Original document created by comments of 31 companies, originally UK

Revision following comments from Europe and USA

Revision includes Supplier and User sections

Broadened scope in line with regulatory requirements and new industries. More responsibility on Users

The guide has been broadened to incorporate a closer relationship with the ideals of system validation. The following sections identify the top-level features of the GAMP guide.

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生产自动化管理规范......

Validation Overview

Validation is applied to many aspects of pharmaceutical manufacturing, including

instrumentation, systems cleaning etc. In each case the objective is to produce “documented evidence, which provides a high degree of assurance that all parts of a facility will

consistently work correctly when brought on-line”. Traditionally, validation has consisted of the following:

Design Qualification (DQ) - Documented evidence that the design of the system meets requirements

Installation Qualification (IQ) - System has been installed correctly Operational Qualification (OQ) - System operates according to design

Performance Qualification (PQ) - System meets design criteria, and operates according to requirement

Traditionally, each of the ‘Qualification’ sections has contained both the specification and the test protocols aimed at verifying that each stage is completed. The term Validation Protocol is often used when referring to these documents.

The guide recommends the use of supplier documents, if suitable. Documents provided by the supplier will simplify the overall validation process. Many of the tests performed by suppliers meet (or exceed) the site requirements for IQ and OQ, and often become reference documents for the User to direct a testing matrix toward. System Documentation

The documentation for an automated system should follow the “V” model. This model shows how the three main qualification activities can be linked back to the design process. The V model principle works well for smaller straightforward systems, such as a monitoring system, which has little or no integration into site wide services.

The document which initiates the validation process is the User Requirement Specification (URS). This describes the equipment or system as it is supposed to work and is normally written by the system user. The original version issued for quotation should normally contain the essential requirements (musts) and the desirable requirements (wants). The final version then accommodates all the musts, which can be met, and any of the wants, which also can be satisfied. The URS is now a standard document required for companies to meet the ISO9001: 2000 standards.

The Function Design Specification (FDS or FS) is normally written by the supplier and describes the functions of the equipment or system. The FDS links to the OQ as each major parameter stated should be tested. The FDS is also a standard output document required by ISO 9001: 2000.

生产自动化管理规范......

The documentation then includes the system build and testing of the installed components. These documents are the testing qualifications IQ, OQ and PQ. At given stages during the lifecycle of the project, planned and systematic reviews should be performed. The design reviews evaluates the deliverables against standards and requirements. The overall validation lifecycle is therefore:

Development Activities User Requirements Specification Functional Specification

Hardware Design Specification Software Design Specification Network Design Specification

Package Configuration Specification Hardware Manufacture and Assembly Code Software Modules

Network Manufacture and Assembly Hardware Testing

Software Module Testing Software Integration Testing Package Configuration Testing Hardware Installation Software Installation Network Installation

Hardware Acceptance Testing Network Acceptance Testing System Acceptance Testing

Maintenance Change Control

Maintaining the Validated State

When a system is validated and in operation, measures should be taken to ensure that the system remains in a validated state. This maintenance not only involves the integrity of the hardware and software, but also the documentation. The maintenance of a validated system includ …… 此处隐藏：24325字，全部文档内容请下载后查看。喜欢就下载吧 ……