Author: IspePublisher:
ISBN: 9781946964335
Category :
Languages : en
Pages :
Book Description
ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design
Author: IspePharmaceutical Microbiological Quality Assurance and Control
Author: David RoestiPublisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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
GAMP Good Practice Guide
Author: Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
Book Description
ISPE GAMP® RDI Good Practice Guide
Author: IspeGAMP Good Practice Guide
Author: ISPEPublisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
Book Description
ISPE Baseline® Guide
Author: ISPE: International Society for Pharmaceutical EngineersPublisher:
ISBN: 9781946964106
Category :
Languages : en
Pages : 240
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe
ISBN: 9781931879385
Category : Pharmaceutical industry
Languages : en
Pages :
Book Description
GAMP 5
Author: Sion WynPublisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
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.
ISPE Good Practice Guide
Author: Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
Book Description