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Quality: A Strategic Element in the Success of a Company

The convention opened with a short introduction by Sergio Dompé, President of the convention organiser and the Chairman, Prof Andrea Gazzaniga, Professor of Pharmacy at the University of Milano, who warmly welcomed the upcoming lectures by key experts from across the world in pharmaceutical quality issues. Dr Henning G Kristensen, who at present serves as the Chair of the European Commission and is a member of the Steering committee for the Certificates of Suitability of Drug Substances, spoke first, on The European Pharmacopoeia and its role in the regulatory process, highlighting the difficulties found in the integration of the Pharmacopoeias in the differing European countries.

The message was that European countries need to speak a common technical language and establish an international harmonisation of subjects. Certain uniformity in the terminology related to pharmaceutical products' qualitative characteristics and in the impurities controls, both for the active pharmaceutical ingredients (API) and excipients and for the container materials, should be reached in the next few years. In the 4th Edition of European Pharmacopoeia it is stated that those standards have to be appropriate to the needs of all people engaged in quality controls laboratories and in the manufacturers of starting materials too.


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By Lucia Giardino, Contract Manufacturing Manager at Dompй Spa

Lucia Giardino is Contract Manufacturing Manager for Dompй spa in Italy. In 1994 she graduated from Milano University in Pharmaceutical Chemistry and subsequently qualified as a Pharmacist. Lucia previously worked in the documentation department of an antibiotics manufacturer before moving into R&D as a Documentation Specialist. From 2000 to 2002 Lucia was Regulatory Affairs Specialist in the Corporate Quality Assurance/Regulatory Affairs for an American chemical-pharmaceutical company manufacturing synthesis of API in bulk, after which she joined Dompй spa in 2003.

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Lucia Giardino
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