construction poles & pilings
handbook of stability testing in pharmaceutical development regulations methodologies and best practices
p this handbook is the first to cover all aspects of stability testing in pharmaceutical development . it presents a scientific understanding of regulations and balances methodologies and best practices . comprising 17 chapters it provides a wealth of resources for pharmaceutical companies educational institutions and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners . p topics covered include 1 latest regulations for stability testing including cgmp requirements ich guidelines and global guidances from who asean emro and other regions . 2 post approval considerations and regulatory filing strategies to support a global supply chain . 3 methodologies including development of a stability indicating method method validation and transfer . physical stability non chromatographic methodologies and spectroscopic applications are also discussed . 4 setting specifications monitoring impurities and establishing shelf life of pharmaceutical products . 5 data management including stability reports cmc and discussion of out of specification oos and out of trend oot . 6 usp nf testing in support of stability purposes . 7 current industry best practices on stability operation validation and calibration of stability chambers including considerations for photo stability testing . 8 discussion of matrixing and bracketing to support reduced stability testing . 9 overview of stability programs for biologics and drug in devices pharmaceutical products . p this collective work was written by a group of prominent international experts who have been directly responsible for instituting industry best practices and establishing the current stability guidelines .