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Pharmaceutical Manufacturing and Packing Sourcer
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The word 'change' is a term we either embrace, challenge, or which makes us retreat to a position where we feel its impact the least. Though it is often said that the more things change the more they remain the same, those of us involved with the manufacture of sterile drugs tend to think this statement is more fiction than reality. The changes and challenges now associated with aseptic processing are not only a result of trying to assure safe and effective drugs, but also of the rapid advances in technology.
When asked to write about the challenges the industry faces with regard to the manufacture of sterile products, I am often reminded of asking my grandmother about her recipes for some of my favourite dishes she used to make. She would give me a list of items I needed, but no matter how hard I tried to repeat her actions it never came out tasting the same.
Although aseptic processing is certainly not like cooking, we as an industry are still faced with the same required 'ingredients' - namely the current Good Manufacturing Practices (cGMPs) - but how we get to the end product is what challenges us the most. This article will therefore not attempt to provide a definitive recipe that assures compliance, rather it will serve as a framework for what is required or expected as a result of current industry practices. For good measure it will also highlight a few of the common deficiencies sighted by the Food and Drug Administration (FDA) in the various categories mentioned.
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Industry Events |
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Global Clinical Outsourcing Partnerships
26-27 March 2009, Mariott Hotel, Brussels
This Jacob Fleming event is designed to promote direct business. It features a two-day educational session with case studies, presentations and interactive sessions. This forum offers networking and the forging of new business partnerships in a unique business-driven environment.
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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.
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