ISPE Baseline® Guide

ISPE Baseline® Guide PDF Author: Ispe
Publisher:
ISBN: 9781946964052
Category :
Languages : en
Pages : 240

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Book Description

ISPE Baseline® Guide

ISPE Baseline® Guide PDF Author: Ispe
Publisher:
ISBN: 9781946964052
Category :
Languages : en
Pages : 240

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Book Description


ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities

ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities PDF Author:
Publisher:
ISBN: 9781936379644
Category : Drug factories
Languages : en
Pages : 136

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Book Description


Pharmaceutical Engineering Guides for New and Renovated Facilities

Pharmaceutical Engineering Guides for New and Renovated Facilities PDF Author:
Publisher:
ISBN: 9781931879095
Category : Drug factories
Languages : en
Pages : 0

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Book Description


ISPE Baseline® Guide

ISPE Baseline® Guide PDF Author: Ispe
Publisher:
ISBN: 9781931879729
Category :
Languages : en
Pages :

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Book Description


GAMP Good Practice Guide

GAMP Good Practice Guide PDF Author: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19

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Book Description


Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control PDF 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

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook PDF Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386

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Book Description
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.

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Good Research Practice in Non-Clinical Pharmacology and Biomedicine PDF Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424

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Book Description
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.

Guidelines for Process Safety in Bioprocess Manufacturing Facilities

Guidelines for Process Safety in Bioprocess Manufacturing Facilities PDF Author: CCPS (Center for Chemical Process Safety)
Publisher: John Wiley & Sons
ISBN: 1118009002
Category : Technology & Engineering
Languages : en
Pages : 244

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Book Description
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.

Medicines from Animal Cell Culture

Medicines from Animal Cell Culture PDF Author: Glyn N. Stacey
Publisher: John Wiley & Sons
ISBN: 9780470723784
Category : Science
Languages : en
Pages : 696

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Book Description
Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.