GAMP Good Practice Guide
| Author | : ISPE |
| Publisher | : |
| Total Pages | : 19 |
| Release | : 2002 |
| Genre | : Technology & Engineering |
| ISBN | : 9781931879255 |
Ispe Baseline Pharmaceutical Engineering Guide For New And Renovated Facilities
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ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities
| Author | : |
| Publisher | : |
| Total Pages | : 136 |
| Release | : 2013 |
| Genre | : Drug factories |
| ISBN | : 9781936379644 |
Good Research Practice in Non-Clinical Pharmacology and Biomedicine
| Author | : Anton Bespalov |
| Publisher | : Springer Nature |
| Total Pages | : 424 |
| Release | : 2020-01-01 |
| Genre | : Cardiology |
| ISBN | : 3030336565 |
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
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
Pharmaceutical Manufacturing Handbook
| Author | : Shayne Cox Gad |
| Publisher | : John Wiley & Sons |
| Total Pages | : 1386 |
| Release | : 2008-03-11 |
| Genre | : Science |
| ISBN | : 0470259809 |
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
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.
Guidelines for Process Safety in Bioprocess Manufacturing Facilities
| Author | : CCPS (Center for Chemical Process Safety) |
| Publisher | : John Wiley & Sons |
| Total Pages | : 244 |
| Release | : 2011-12-28 |
| Genre | : Technology & Engineering |
| ISBN | : 1118009002 |
This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.
