How to be an Effective GMP Auditor
An audit is a methodical, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled (ISO 19011:2002, 3.1). In this book, we will share with you the best practices on how to become an effective GMP auditor. This book also serves as an ideal refresher course for anyone who needs to brush up on their current audit knowledge.
Edited by Tim Sandle and Madhu Raju Saghee.
ISBN 978-0-9573491-6-2 (Hb) ISBN 978-0-9956666-0-3 (Pb)
This book describes how to perform the qualification assessment depending upon the impact of individual equipment on product quality. The risk based qualification assessment describes the qualification steps (RA,DQ, IQ, OQ, PQ etc.) required to qualify the equipment. This approach eliminates the duplication of effort and costly practices.
An Easy to Understand Guide to Validating Purified Water Systems
This quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations and standards. You will find this guide especially helpful if you are in the planning phase for a new purified water treatment system, interested in upgrading your current system and new to water treatment projects.