Process Development

Nov 01, 2005
Pharmaceutical Technology Europe
Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.
Sep 01, 2005
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.
Aug 01, 2005
Pharmaceutical Technology Europe
Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.
Aug 01, 2005
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
The question of pharmaceutical pricing is going to be resurrected by the European Commission, despite French President Jacques Chirac's rejection of the new EU treaty. Günther Verheugen, the Commission vice president, made this announcement at the annual meeting of the European Federation of Pharmaceutical Industries and Associates in Brussels (Belgium) responsible for competitiveness.
Mar 01, 2005
Pharmaceutical Technology
The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.
Dec 01, 2004
Pharmaceutical Technology Europe
By Albedo
Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.
Nov 01, 2004
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author argues that information technology solutions will play a major part in confirming—by experimental and statistical validation—that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.
Nov 01, 2004
Pharmaceutical Technology Europe
The implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods — some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter <645> for conductivity, which replaced a series of individual ion tests; and Chapter <643> which replaced the oxidizable substances test with a TOC method.
Oct 01, 2004
Pharmaceutical Technology Europe
FDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.
Sep 01, 2004
Pharmaceutical Technology Europe
Customers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.
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