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.Sager, N., Baum, R. G., Wolters, R. J., and Layloff, T. (1998), Photostability studies of pharmaceutical products, Pharmacopeial Forum, 24(3), 6331. ... tablets and determination of specificity, selectivity, and the stability-indicating nature of the USP ibuprofen assay method, Pharm. ... Grimm W. (1998), Extension of International Conference on Harmonization tripartite guideline for stability testing of new druganbsp;...
|Title||:||Pharmaceutical Manufacturing Handbook|
|Author||:||Shayne Cox Gad|
|Publisher||:||John Wiley & Sons - 2008-04-04|