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Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
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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.
Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
Get Book Here
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.
Author: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
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Book Description
Author: Ispe
Publisher:
ISBN: 9781946964144
Category :
Languages : en
Pages : 148
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Book Description
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author:
Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
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Book Description
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971116
Category : Medical
Languages : en
Pages : 740
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Book Description
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: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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Book Description
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: William M. (Bill) Huitt
Publisher: John Wiley & Sons
ISBN: 1119284252
Category : Technology & Engineering
Languages : en
Pages : 610
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Book Description
The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Author: Sam A. Hout
Publisher: CRC Press
ISBN: 1000406091
Category : Technology & Engineering
Languages : en
Pages : 207
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Book Description
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.
Author: International Society of Pharmaceutical Engineers
Publisher:
ISBN: 9781936379422
Category : Laboratories
Languages : en
Pages : 172
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Book Description
