List view / Grid view
19 June 2008 | By
Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…
19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals
In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…
19 June 2008 | By
PAT implementation gurus’ Expo Technologies talks to European Pharmaceutical Review about PAT and why they are at the top of their game.
19 June 2008 | By
The ease in making process analytical measurements (typically spectroscopic) in manufacturing has provided a unique opportunity to obtain up-to-date information for making timely process correction decisions. At-line methods provide near-time information without the need for elaborate process control interfacing upfront. This approach works well for batch processing applications or unit…
19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a…
7 April 2008 | By
Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…
7 April 2008 | By
The pharmaceutical industry has, for many years, operated in a special environment with strong regulation and patent protection. Production efficiency and yields have not, as in many other industries, been the major competition parameter and, as a result of this, pharmaceutical manufacturing has a low manufacturing performance compared to other…
7 April 2008 | By
Contract Research Organisations (CROs) provide independent development services for pharma, biotechnology, and medical device markets. Services offered by CROs have evolved from providing basic support, to a wide range of services catering to various needs of the market and the sponsors. The United States is the world’s largest market for…
7 April 2008 | By
Research within the pharmaceutical industry has tripled in the past 25 years, with the pipelines of the top companies doubling. Stricter regulations, guidelines, price and reimbursement legislation all result in a changing business environment. The growing market in drug development and increase in research and development (R&D) investment, including that…
7 April 2008 | By
In the highly competitive contract manufacturing outsourcing (CMO) market the industry is on the rise with pharmaceutical and biotechnology companies targeting their resources towards marketing, rather than production and drug discovery. Pharmaceutical and biopharmaceutical companies are faced with the need to outsource the manufacture of their products for a variety…
Testing cleaning validation samples requires a validated method. The extent of validation is dependent upon the type of method employed, the capabilities of the method, the scientific and regulatory needs of the resulting data and the anticipated outcome of the testing. A number of test method options are reviewed for…
19 March 2008 | By
The process analytical technology guidelines have been a hotly debated topic within the pharmaceutical industry ever since they were made public in 2004. This also holds true at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), Division of Janssen Pharmaceutical N.V. In recent years, the company has introduced PAT tools…
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
23 January 2008 | By Hans H. Schicht, Dr. sc. Techn, Dr. Hans Schicht Ltd
There are many trends worth reporting in the context of pharmaceutical cleanroom technology: technical as well as regulatory trends. Supporting them is the continuing trend towards worldwide international standards, not only regarding contamination and biocontamination technology, but also regarding related topics such as air filtration. The endeavours for controlling micro-organisms,…
This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…
