Much has happened in the areas of bulk pharmaceutical good manufacturing practice, (GMP) and validation since the first edition of this book. Validation of Active Pharmaceutical Ingredients introduces the new terminology and better difines old terminology. New information and global regulatory guidance for current GMP, stability, product quality requirements and post-approval changes are included. The reader will gain a better understanding of the regulatory process in order to facilitate compliance by the regulated pharmaceutical industry. Updates to chapters from the first editions, as well as several additional chapters on subjects such as postapproval changes, technology transfer, international cGMP guidelines / FDA guidance progress, and facility inspectional issues, are included.