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22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting
Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.
20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS
The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…
20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D
In the last decade interest in Rapid Microbiological Methods (RMMs) 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 lot of confusion and…
7 March 2005 | By Jukka Rantanen, Senior Research Scientist, Viikki Drug Discovery Technology Centre, University of Helsinki
There is an increasing demand for new approaches to understand the chemical and physical phenomena that occur during pharmaceutical unit operations. Obtaining real-time information from processes opens new perspectives for safer manufacture of pharmaceuticals. Raman spectroscopy provides a molecular level insight into processing and it is therefore a promising process…
7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.
Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.
