Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)
Détails
Etat: Public
Version: Après imprimatur
Licence: Non spécifiée
ID Serval
serval:BIB_F67CDDA6DB09
Type
Mémoire
Sous-type
(Mémoire de) formation continue
Collection
Publications
Institution
Titre
Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)
Directeur⸱rice⸱s
Diezi Jacques
Détails de l'institution
Université de Lausanne, Faculté des hautes études commerciales
Adresse
Lausanne
Statut éditorial
Acceptée
Date de publication
2008
Genre
Mémoire / Institute of Health Economics and Management ; no 121
Langue
anglais
Nombre de 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
Résumé
[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
Mots-clé
Pharmaceutical Preparations, Quality Control, Costs and Cost Analysis
Site de l'éditeur
Création de la notice
05/07/2010 16:52
Dernière modification de la notice
09/02/2023 7:51
Données d'usage
