Faithin Omaha eBook Collection

Download or read book Validation of Bulk Pharmaceutical Chemicals written by Daniel Harpaz and published by Interpharm CRC. This book was released on 1997-01-01 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fourteen contributions offer definitive guidance to both the manufacturer and the purchaser of bulk pharmaceutical chemicals on the legal, regulatory, and manufacturing process for active pharmaceutical ingredients and excipients. The text emphasizes validation, the key element of good manufacturing practice, with information from a group of industry experts on facilities, procedures, quality assurance, and other functions. Acceptable and achievable practices and regulatory requirements of the dosage form sector of the pharmaceutical industry are related to the bulk pharmaceutical chemical (BPC) producer in chapters which cover topics such as: the legal framework for the regulation of BPCs, drug master files, quality assurance systems, and vendor qualification and certification. Annotation copyrighted by Book News, Inc., Portland, OR