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.
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