Pharmaceutical Engineering Guides for New and Renovated Facilities PDF Download
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Author:
Publisher:
ISBN: 9781931879095
Category : Drug factories
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN: 9781931879095
Category : Drug factories
Languages : en
Pages : 0
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Book Description
Author: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
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Book Description
Author:
Publisher:
ISBN: 9781936379644
Category : Drug factories
Languages : en
Pages : 136
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Book Description
Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1315355027
Category : Medical
Languages : en
Pages : 674
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Book Description
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Author: Ispe
Publisher:
ISBN: 9781946964052
Category :
Languages : en
Pages : 240
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Book Description
Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1482258919
Category : Medical
Languages : en
Pages : 535
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Book Description
This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
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Book Description
GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Author: International Society for Pharmaceutical Engineering
Publisher:
ISBN: 9781936379149
Category : Drug development
Languages : en
Pages : 200
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Book Description
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author: Ispe
Publisher:
ISBN: 9781946964144
Category :
Languages : en
Pages : 148
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Book Description
