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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.
GDP is an essential skill you need to have when you’re working in the life science sector. GDP is not just about initials and dates (although it does play a big part of it) it’s about doing things the right way and making everything you do transparent. Honesty is the best policy and when you’re making medicinal products its essential you follow the rules.
Edited by Tim Sandle and Madhu Raju Saghee.
ISBN 978-0-9573491-6-2 (Hb) ISBN 978-0-9956666-0-3 (Pb)
Deskbook of Pharmaceutical Dissolution Science and Applications , has been contributed and written by Expert Scientists across the Globe. The aim to provide the Academia, Industry and Research Scientists an overview of Basics and Fundamentals in the dissolution science and testing, recent developments in instrumentation and automation, changing regulatory requirements and innovations in the area of dissolution science and dissolution / in vitro release for novel dosage forms. The chapters provide details about the instrument operations, tip to overcome problems in desing and development with adequate literature citations. The chapters also reveal methods of statistical analysis and interpretation of dissolution test data; application of data in terms of correlation with bioavailability and bioequivalence. This is a unique book of its kind
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.
Reagent Chemicals Specifications and Procedures for Reagents and Standard-Grade Reference Materials Eleventh editionRs13,065.00
Edited by Paul Bouis
American Chemical Society
Published by: American Public Health Association, USA (APHA)
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims, experienced folks will likely find nuggets to help improve their efforts.