Handbook of Stability Testing in Pharmaceutical Development - Regulations, Methodologies, and Best Practices

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. 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. 

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.