By Robert McGregor, Brookfield Engineering Laboratories Dosing is that critical step in producing a consumer product where manufacturing wants things to go as smoothly as possible. Two issues that affect acceptance are volume of material in the dose and proper proportions for constituent ingredients. This application note addresses the situation for both liquid and powder-based products.
By Kjell Francois, Siemens AG PAT (Process Analytical Technology) and QbD (Quality by Design) are the current buzzwords in the pharmaceutical industries, claiming to reduce waste, increase R&Q (reliability and quality) and production yields, and finally, to reduce costs. But introducing and implementing PAT, for instance, into an oral solid dose (OSD) plant, is a complex matter, and requires integration of different sources of data and different business layers. This article tries to give insight into this complexity, describing the different kinds of data, each with their specific properties.
By Rusty Nelson, Daiichi Jitsugyo (America), Inc. A pharmaceutical client was at risk of a product recall due to a capping problem with a new tablet formulation. Visual inspection at the packaging plant had identified that capped/laminated tablets had made it through to the packaging stage despite the tablets having met intermediate quality inspection.
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By Mike Kuehne, ACSYS, Inc. Organizations that consistently develop and launch new products efficiently, in an environment of increasing regulatory scrutiny successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of pharmaceutical development and manufacturing through a review of regulatory trends during the period from Q1, 2011 through Q2, 2012.