Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

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Ressource 1Download: BIB_F67CDDA6DB09.P001.pdf (822.96 [Ko])
State: Public
Version: After imprimatur
Serval ID
serval:BIB_F67CDDA6DB09
Type
A Master's thesis.
Collection
Publications
Institution
Title
Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)
Author(s)
Apara Charles
Director(s)
Diezi Jacques
Institution details
Université de Lausanne, Faculté des hautes études commerciales
Address
Lausanne
Publication state
Accepted
Issued date
2008
Genre
Mémoire / Institute of Health Economics and Management ; no 121
Language
english
Number of pages
34 f.
Notes
Master of Advanced Studies en économie et politique du médicament - Master of Advanced Studies in Pharmaceutical Economics and Policy (MASPEP) Mention de responsabiblité : / Charles Apara ; project director: Jacques Diezi ; expert: Nathalie Wardé SAPHIRID:78488
Abstract
[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology methods
Keywords
Pharmaceutical Preparations , Quality Control , Costs and Cost Analysis
Create date
05/07/2010 16:52
Last modification date
20/08/2019 17:22
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