Modern tablet production facilities are faced with two increasingly important, yet contradictory, demands - being able to handle more potent drugs and, at the same time, reduce costs. Additionally, batch sizes must become smaller and production planning more flexible. Until recently, these issues could only be dealt with individually and not as a whole; however, the exchangeable functional module (EFM) may provide a solution to this problem, as this article describes.
Europe's pharmaceutical R&D has recently come under a barrage of criticism. Nobel laureate, Kary Mullis, highlighted the issue of over-legislating biotechnology and the business industry expressed its dismay concerning the EU's overly cautious approach to any kind of development. Action is needed before the sector's future resembles the plot of a Shakespearean tragedy.
This article is intended to keep readers informed about the developments concerning the local language requirements for European Union member countries. The first part deals with the reasons why these language requirements are about to become more difficult to meet and the second part, based on recent application knowledge, offers some potential solutions.
For nearly 40 years, drug dossiers have supported the quality, safety and risk/benefits of medicinal products. However, electronic technological advances mean that the dossier will soon be a thing of the past - being replaced by e-documents that can be reviewed and approved online by regulators, under the scrutiny of patient groups and with the final blessing of purchasers, as this article examines.
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.