Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)
Details
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State: Public
Version: After imprimatur
License: Not specified
Serval ID
serval:BIB_F67CDDA6DB09
Type
A Master's thesis.
Publication sub-type
Continuing education (thesis)
Collection
Publications
Institution
Title
Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)
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
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
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Create date
05/07/2010 16:52
Last modification date
09/02/2023 7:51