GAMP – Test Phases and Sequencing
07/10/2015
.Good Automated Manufacturing Practice (GAMP) – Test Phases and Sequencing This article was written by Iian Shaya, validation,automation and control expert
.Good Automated Manufacturing Practice (GAMP) – Test Phases and Sequencing This article was written by Iian Shaya, validation,automation and control expert
Good Automated Manufacturing Practice (GAMP) Definition of Terms Definition of Terms Used in Testing Environments This document provides a definition of a set of testing
The third part of our Validation case study includes Documentation for IQ and OQ – to be checked at PDI/FAT, DQ Protocols Including PC/PLC, IQ Protocols Including PC/PLC, OQ Protocols Including PC/PLC, PQ Protocols Including PC/PLC
The second part of our case study deals with the Validation Requirements of Documentation for Initial Tender,Documentation for Design Review,Documentation Prior to FAT or Pre-Delivery Inspection – PDI& Commissioning
This is the first part of Validation Requirements – case study, it covers Document Contents & Responsibility
ולידציה – Function Design Specification- FDSPreparation Overview
ולידציה – Testing Process Automation Systems – Testing Responsibilities Supplier and User
ולידציה -Testing and HW/SW Type and Maturity – GAMPProcess automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.
This article cover the third part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for Factory Acceptance Test – FAT, Site Acceptance Test – SAT / Installation Qualification – IQ, Operation Qualification – OQand Performance Qualification – PQ
This article cover the first part of our Good Automated Manufacturing Practice (GAMP) test example.
