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Administration of Quality Standards and Registration of Pharmaceutical Excipients in China
'by' Ling Su, Jingyi Leung, and Phoon Bee Lim
This article presents the definition of pharmaceutical excipients, pharmaceutical excipient standard and categories, pharmaceutical excipient submission requirements, and imported pharmaceutical excipient registration procedures in China.Download Article...
Facility of the Future
'by' Active Pharmaceutical Ingredients Community of Practice (API COP)
This article presents a perspective on what the Facility of the Future will look like as envisioned by ISPE’s API community. The concepts in the article will form the basis of a series of planned ISPE Guidance Documents.Download Article...
Resource Planning in QC Laboratories
'by' Rafi Maslaton
This article presents a methodology and approach to resource planning, including both analysts and instruments in QC laboratories.Download Article...
Applying Fault Tree Analysis (FTA) as a Top Level Risk Management Tool in Software Development
'by' Paul Noble, PhD
This article presents the case that fault tree analysis is the better risk analysis method to apply early in software development projects.Download Article...
Control Strategy as the Keystone of the Product Lifecycle, from Product/Process Understanding to Continuous Process Verification and Improvement
'by' Johanne Piriou, Bernard Elissondo, Michel Hertschuh and Roland Ollivier
This article presents the general principles of Control Strategy (CS) and its evolution. A method for designing a CS and its filing in Common Technical Document (CTD) format are proposed. CS within the continuous process verification and product lifecycle is discussed.Download Article...
Global Regulatory News
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A Risk Assessment Approach to Planning an API Production Facility
'by' Kazuo Tozaki
This article presents a new risk assessment table and discusses associated issues, including the targets of assessment, criticality, contents of the risk factors, and severity.Download Article...
Inhibitory Effect of Silkworm Extract on Alpha-Glucosidase Activity and Postprandial Blood Glucose in Mice
'by' Juan Cueva, Patricio Castillo, Giovanna Allara-Salice, and Angel Guevara
This article was developed from the presentation by a finalist in the ISPE 2010 Undergraduate International Student Poster Competition.Download Article...
Inhibitory Effect of Silkworm Extract on Alpha-Glucosidase Activity and Postprandial Blood Glucose in Mice
'by' Juan Cueva, Patricio Castillo, Giovanna Allara-Salice, and Angel Guevara
This article was developed from the presentation by a finalist in the ISPE 2010 Undergraduate International Student Poster Competition.Download Article...
