Computer System Validation GAMP-5

GAMP5 :-

GAMP stands for Good Automated Manufacturing Practice. Usually, when one hears the terms GAMP5, it is in reference to a guidance document entitled GAMP5: A Risk-Based Approach to Compliant GxP Computerized Systems. This document is published by an industry trade group called the International Society for Pharmaceutical Engineering (ISPE)based on input from pharmaceutical industry professionals.

GAMP Categories

The GAMP categories were originally introduced to provide an initial assessment as to the validation requirements / deliverables.

These have been revised in GAMP5 to four categories as detailed below:

v  Category 1 – Infrastructure software including operating systems, Database Managers, etc.

v  Category 3 – Non configurable software including, commercial off the shelf software (COTS), Laboratory Instruments / Software.

v  Category 4 – Configured software including, LIMS, SCADA, DCS, CDS, etc.

v  Category 5 – Bespoke software/ Customize Software

Category 2 from GAMP 4 has been removed. This related to firmware

v  Hardware Category 1 – Standard Hardware Components

v  Hardware Category 2 – Custom Built Hardware Components

Why Categorise

In GAMP 3 and GAMP 4 the purpose of the GAMP categories had clear purpose, identifying which validation deliverables were not required. Categories 1-3 were considered to standard systems and the System Life Cycle Design (SLCD) documentation were not required, this included

v  Supplier Audits

v  Functional Specifications

v  Source Code Reviews


Note :- This is Only Knowledge Purpose and Blog Contain is my View  + Internet Search and Guideline.