Vessel Validation : Biotechnology Plants : Pharmaceutical Plants : Medical Device Plants : Risk-Based Qualification Protocols : PlantValidation.com

A Digital Book, 2012 Edition

PHARMACEUTICAL PLANT VALIDATION

TABLE OF CONTENTS
PROTOCOL DESCRIPTIONS
DQ, IQ, OQ AND PQ (*) PROTOCOLS
- PROCESS EQUIPMENT AND SYSTEMS
- CLEAN UTILITY SYSTEMS
- SUPPORT SYSTEMS
- HVAC SYSTEMS AND CLEANROOMS
- LABORATORY EQUIPMENT
(*): PQ Protocols Available

Welcome to Current Validation Practice Guide

Risk-Based Qualification / Validation Protocols

The Risk-Based DQ, IQ, OQ and PQ Protocols are convenient to use for utilizing the GEP (Good Engineering Practice) Design and Commissioning data as the evidence of Qualification. The DQ Protocol is for systematic design review and documentation, while the IQ and OQ Protocols for flexible verification and documentation accepting test data from Commissioning including FAT and SAT, thus enabling to avoid repetition of the same verification activities. The protocols will help save time and cost for validation throughout the product and system life-cycle.

This Book Is For You!

Validation Engineers
Examples of detailed DQ, IQ, OQ and PQ protocols for major process systems, clean utility systems, HVAC systems and cleanrooms, and laboratory equipment will provide you with information on what quality-critical attributes and technical attributes need to be verified in DQ and how to incorporate DQ into the regular engineering practices and further qualifications for IQ, OQ and PQ, eventually allowing you to save time and effort for successful completion of your validation project.

Equipment Manufacturers
Examples of detailed DQ, IQ, OQ and PQ protocols of this book will guide you to readily prepare protocols for your own equipment by adapting the example protocols to the service conditions of your own equipment, enabling you to have the qualification protocols of your equipment available for your customers.

Plant Engineers and Facility Engineers
Examples of detailed DQ, IQ, OQ and PQ protocols for the GMP plants that have been used for approval by different authorities in various nations worldwide will guide you to easily create your own protocols by adapting the examples of this book to the specific service conditions of your own plant.

Project Engineers and Project Managers
Examples of detailed DQ, IQ, OQ and PQ protocols of this book will allow you to obtain practical and accurate information on what needs to be prepared for qualification of the facility of your project, ultimately enabling you to save time and cost for plant commissioning and validation.

QA/QC Engineers
Examples of detailed DQ, IQ, OQ and PQ protocols for the GMP plants, that have been used for inspections by authorities in various nations worldwide, will provide you with the information on what quality-critical attributes and technical attributes need to be verified for your own facility. The examples of this book will guide you to readily prepare protocols for your own laboratory equipment units as well as major process and clean utility systems.

Plant Design Engineers
Examples of detailed DQ, IQ, OQ and PQ protocols for the GMP plants will guide you to prepare your own protocols for the plants you have designed by adapting the examples of this book to the process conditions of your plants, and thus allow you to easily expand your knowledge and expertise to the area of plant validation.