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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Author:
Publisher:
ISBN: 9781931879095
Category : Drug factories
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN: 9781936379644
Category : Drug factories
Languages : en
Pages : 136
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Author: International Society for Pharmaceutical Engineering
Publisher:
ISBN: 9781936379088
Category : Pharmaceutical industry
Languages : en
Pages : 116
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Author: Ispe
Publisher:
ISBN: 9781946964052
Category :
Languages : en
Pages : 240
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Author:
Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
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Author: Ispe
Publisher:
ISBN: 9781946964144
Category :
Languages : en
Pages : 148
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Author: Ispe
Publisher:
ISBN: 9781931879729
Category :
Languages : en
Pages :
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Author: Ispe
Publisher:
ISBN: 9781936379934
Category :
Languages : en
Pages : 178
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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: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
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