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|Title:||Assessing the impact of the new ICH Q10 standard on the pharmaceutical industry|
Zammit, Marie Clare
Zarb Adami, Maurice
Azzopardi, Lilian M.
|Keywords:||Pharmaceutical industry -- Quality control -- Malta|
Pharmaceutical industry -- Quality control -- Documentation
Pharmaceutical industry -- Standards -- Malta
|Publisher:||University of Malta. Department of Pharmacy|
|Citation:||Baldacchino, I., Wirth, F., Zammit, M. C., Zarb Adami, M., Azzopardi, L. M., Serracino-Inglott, A., & Zahra, A. (2010, March). Assessing the impact of the new ICH Q10 standard on the pharmaceutical industry. Poster session presented at the 7th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Valletta, Malta.|
|Abstract:||A poster presentation on assessing the impact of the new ICH Q10 standard on the pharmaceutical industry. Introduction: The ICH Q10 describes a model for a good and effective pharmaceutical quality system which is based on International Standards quality concepts and Good Manufacturing Practice (GMP). The aim of this study was to assess the impact of the ICH Q10 guideline in a live pharmaceutical quality system achieved by the compilation and distribution of a questionnaire. A gap analysis of the system was also performed.|
|Appears in Collections:||Scholarly Works - FacM&SPha|
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