Known as the "Orange guide". Also available: printed version (ISBN 9780853697190); a single user CD-ROM version (ISBN 9780853697206). Supersedes any previous editions
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
"Pharmaceutics is the art of pharmaceutical preparations. It encompasses design of drugs, their manufacture and the elimination of micro-organisms from the products. This book encompasses all of these areas."--Provided by publisher.
This is a guide to computer-readable databases available online, in CD-ROM format, or in other magnetic formats. Details include database descriptions, costs, and whom to contact for purchase. The material is indexed alphabetically, and by subject, vendor, and producer.
An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.