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Author :
Publisher :
ISBN 13 : 9781931879569
Total Pages : 104 pages
Book Rating : 4.8/5 (795 download)
Download or read book ISPE Good Practice Guide written by and published by . This book was released on 2009 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964120
Total Pages : 176 pages
Book Rating : 4.9/5 (641 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2018-11-30 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964175
Total Pages : 204 pages
Book Rating : 4.9/5 (641 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-03-25 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964144
Total Pages : 148 pages
Book Rating : 4.9/5 (641 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781931879361
Total Pages : 80 pages
Book Rating : 4.8/5 (793 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2005-09-05 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : ISPE
Publisher :
ISBN 13 : 9781931879255
Total Pages : 19 pages
Book Rating : 4.8/5 (792 download)
Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : International Society of Pharmaceutical Engineers
Publisher :
ISBN 13 : 9781936379422
Total Pages : 172 pages
Book Rating : 4.3/5 (794 download)
Download or read book ISPE Good Practice Guide written by International Society of Pharmaceutical Engineers and published by . This book was released on 2012 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.5/5 (276 download)
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author : International Society for Pharmaceutical Engineering
Publisher :
ISBN 13 : 9781936379446
Total Pages : 140 pages
Book Rating : 4.3/5 (794 download)
Download or read book Ozone Sanitization of Pharmaceutical Water Systems written by International Society for Pharmaceutical Engineering and published by . This book was released on 2012 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971116
Total Pages : 740 pages
Book Rating : 4.1/5 (189 download)
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author :
Publisher :
ISBN 13 : 9781936379064
Total Pages : 135 pages
Book Rating : 4.3/5 (79 download)
Download or read book ISPE Good Practice Guide written by and published by . This book was released on 2011 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879422
Total Pages : pages
Book Rating : 4.8/5 (794 download)
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.8/5 (793 download)
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781936379989
Total Pages : 128 pages
Book Rating : 4.3/5 (799 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2017-06-27 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.8/5 (796 download)
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Nuala Calnan
Publisher : CRC Press
ISBN 13 : 1315351366
Total Pages : 516 pages
Book Rating : 4.3/5 (153 download)
Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Author : Sam A. Hout
Publisher : CRC Press
ISBN 13 : 1000406091
Total Pages : 206 pages
Book Rating : 4.0/5 (4 download)
Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-05 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
