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Pharmaceutical Manufacturing and Packing Sourcer

Stability Issues and Outsourcing Solutions

Stability studies are an essential element of the drug development process. The purpose of a stability study is to provide evidence on how the quality of a drug substance or drug product varies over time when subjected to a variety of environmental factors, such as temperature, humidity and light. This information can then be used to ascertain a re-test period for the drug substance or determine the shelf life of a product. Additionally, specific recommendations can be made with regard to appropriate storage conditions and optimum packaging systems.

Depending on the scale of the study - the number of product lots involved, dosage strength, storage conditions and duration - a typical stability study will place a heavy burden on resources and personnel. It will also generate a huge amount of data that will need to be processed and interpreted.


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By Elma Brennan, Head of the Pharmaceutical Laboratory at RSSL Pharma

Elma Brennan joined RSSL Pharma in 1995 and has helped establish the company as a leading supplier of contract analytical solutions to the pharmaceutical industry. She is now Head of the Pharmaceutical Laboratory at RSSL Pharma.

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Elma Brennan
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EMBALLAGE 2008. World Packaging Exhibition

16-21 November 2008, Paris-Nord Villepinte - France

“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
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“PACK DIFFERENT” with EMBALLAGE 2008

“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >>

 

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