Ispe Gampr Rdi Good Practice Guide
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Pharmaceutical Microbiological Quality Assurance and Control
| Author | : David Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 594 |
| Release | : 2020-01-02 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356075 |
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 |
| Total Pages | : |
| Release | : 2005-01-01 |
| Genre | : Technology & Engineering |
| ISBN | : 9781931879392 |
ISPE Baseline® Guide
| Author | : ISPE: International Society for Pharmaceutical Engineers |
| Publisher | : |
| Total Pages | : 240 |
| Release | : 2018-04-25 |
| Genre | : |
| ISBN | : 9781946964106 |
GAMP Good Practice Guide
| Author | : ISPE |
| Publisher | : |
| Total Pages | : 19 |
| Release | : 2002 |
| Genre | : Technology & Engineering |
| ISBN | : 9781931879255 |
GAMP Good Practice Guide
| Author | : |
| Publisher | : Ispe Headquarters |
| Total Pages | : |
| Release | : 2005 |
| Genre | : Technology & Engineering |
| ISBN | : 9781931879422 |
GAMP 5
| Author | : Sion Wyn |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2008 |
| Genre | : Computer systems |
| ISBN | : 9781931879613 |
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 | : |
| Total Pages | : 104 |
| Release | : 2009 |
| Genre | : Pharmaceutical industry |
| ISBN | : 9781931879569 |
ISPE Good Practice Guide
| Author | : International Society of Pharmaceutical Engineers |
| Publisher | : |
| Total Pages | : 172 |
| Release | : 2012 |
| Genre | : Laboratories |
| ISBN | : 9781936379422 |
