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GAMP

Good Autmated Manufacturing Practices
URL:
http://www.gamp.org/

GAMP 4 Released

GAMP 4, the GAMP Guide for Validation of Automated Systems, has been released in December in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems. It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation. 
GAMP 4 is a significant advance on previous versions of this widely accepted guidance on validation of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the GAMP Industry Board
To order GAMP 4, please visit http://www.ispe.org/

GAMP 3

The gamp 3 guide is produced by the GAMP Forum which was established by representatives from major international companies, to interpret and improve understanding of regulations regarding the use of automated systems in pharmaceutical manufacturing.It    helps users understand the requirements for validation of an automated system and the level to which the validation should be performed. It helps suppliers ensure that systems are developed according to good practice, and to provide documentary evidence that their system meet the agreed specification.

GAMP 3 is considerably revised and enhanced compared to the previous version, GAMP 2.0 / 96. It includes new material and has been reconstructed for ease of use.

Volume 1, Part 1 - User Guide
Outlines the requirements for validation or automated systems and describes the role of the pharmaceutical user organisation in this process.

Volume 1, Part 2 - Supplier Guide
Describes the quality requirements for a supplier of automated systems to the pharmaceutical industry and describes the proposed management system for such suppliers.

Volume 2, Good Practice Examples
Contains Good Practice definitions, and guidance on application of Good Practice to various systems.

New Material includes guidance on:

Validation Planning
User Quality & Project Planning
Revised Management Systems for Suppliers
Revised Management Systems for Process Control Systems
Configuration Management
Specification and Testing of System Interfaces
Good Documentation Practice
Good Engineering Practice
Validation of Information Systems
Validation of Process Control Systems

 A major addition is the GMA/NAMUR guidance on a methodology for the management of projects for automated plant control on a large scale.

This Includes:
Execution of Process Control
Projects subject to Validation
Operation and Maintenance of Validated Systems (On Going Validation)
Validation Support by use of Control Systems
Suppliers of automated systems and their customers in the pharmaceutical industry will benefit by adopting the principles defined in GAMP 3.
Among thebenefits accorded are improved visibility of projects to ensure delivery of projects on time, on budget and to agreed quality standards. Use of GAMP 3 also brings a common understanding of the purpose and process of validation as well as reduced validation costs and timetables. In addition, it eliminates the need for costly retrospective validation.

GAMP 3 has been endorsed by the Association of the British Pharmaceutical Industry (ABPI) and the Pharmaceutical Quality Group of the Institute of Quality Assurance.

For the development and implementation of new computer systems used in the manufacture of drug products, the International Association for Pharmaceutical Technology (APV) recommends GAMP 3 as the technical basis for the contractual agreements between supplier and user.




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