Validaton de salles propres et stériles dans l'industrie pharmaceutique PDF Download
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Author: Charline Lailler
Publisher:
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Languages : fr
Pages :
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Author: Charline Lailler
Publisher:
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Languages : fr
Pages :
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Author: VINCENT.. ARNAVIELLE
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Languages : fr
Pages :
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Author: Agnès Caddeo
Publisher:
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Languages : fr
Pages : 328
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Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590
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Book Description
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
Author: Sam A Hout
Publisher: CRC Press
ISBN: 9780367754372
Category :
Languages : en
Pages : 208
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This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Author: Julien Laizé
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Languages : fr
Pages :
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Dans l’industrie pharmaceutique, la qualification et la validation font parties des bonnes pratiques de fabrication des médicaments, ce qui en fait un exigence réglementaire pour laquelle les organismes nationaux de contrôle attachent un intérêt croissant. Mais ce sont avant tout des outils puissants qui permettent à l’industriel de garantir la qualité de ses produits vis-à-vis du public. Les médicaments stériles font l’objet de contraintes encore plus exigeantes. C’est pourquoi, qualification et validation font l’objet d’un soin particulier. Ce mémoire explique ces notions et décrit trois exemples concrets de qualification et de validation et milieu stérile.
Author: LAURENT.. APERT
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Languages : fr
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Author: Marion Lindecker
Publisher:
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Category :
Languages : fr
Pages : 124
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Author: ANNE-MARIE.. BRUNET
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Languages : fr
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Author: Katell Barillier
Publisher:
ISBN:
Category :
Languages : fr
Pages : 244
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