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.
ABOUT THE AUTHOR Daniel Harpaz
Daniel Harpaz is President of Harpaz Consulting Services, which provides global regulatory and technical advice to FDA regulated industries. He has over 30 years' experience in the pharmaceutical industry, holding postitions in R & D, quality control, and engineering. Dr. Harpaz has made numerous.
ABOUT THE AUTHOR Ira R. Berry
Ira Beerry is Executive Vice President of Wockhardt Americas Inc. where he is responsible for global regulatory affairs and quality assurance, the U.S. operation, and for establishing new manufacturing and technical operation worldwide. Hiw experience includes service at Banner Pharmacaps, Inc., Pfizer, and Denver Chemical Manufacturing Co. Mr. Berry has published more than 25 papers and holds several patents, presentations and published in the areas of GMP and validation issues.
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