Process Development

Nov 01, 2006
Pharmaceutical Technology Europe
Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.
Oct 01, 2006
Pharmaceutical Technology Europe
Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.
Sep 01, 2006
Pharmaceutical Technology
Companies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.
Apr 01, 2006
Pharmaceutical Technology Europe
All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.
Dec 01, 2005
Pharmaceutical Technology Europe
In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.
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.
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