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Author : Ispe
Publisher :
ISBN 13 : 9781931879958
Total Pages : 352 pages
Book Rating : 4.8/5 (799 download)
Download or read book Ispe Gamp® 5 written by Ispe and published by . This book was released on 2010-08-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Good Automated Manufacturing Practice Forum
Publisher :
ISBN 13 : 9781936379484
Total Pages : 156 pages
Book Rating : 4.3/5 (794 download)
Download or read book A Risk-based Approach to GxP Compliant Laboratory Computerized Systems written by Good Automated Manufacturing Practice Forum and published by . This book was released on 2012 with total page 156 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 :
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 :
Publisher :
ISBN 13 : 9781931879682
Total Pages : 212 pages
Book Rating : 4.8/5 (796 download)
Download or read book A Risk-based Approach to Operation of GxP Computerized Systems written by and published by . This book was released on 2009 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9240086080
Total Pages : 1354 pages
Book Rating : 4.2/5 (4 download)
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241210281
Total Pages : 303 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2019-05-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting
Publisher : World Health Organization
ISBN 13 : 9241209968
Total Pages : 374 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting and published by World Health Organization. This book was released on 2016 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality, safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines, from their development to their distribution to patients. In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM), the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS. It noted the report on Phase 6 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further acknowledged the progress of good pharmacopoeial practices (GPhP), and adopted the document on GPhP which was prepared by the consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP), distribution and trade of pharmaceuticals and regulatory practice. It adopted 10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.
Author : Kim Huynh-Ba
Publisher : John Wiley & Sons
ISBN 13 : 1119120918
Total Pages : 420 pages
Book Rating : 4.1/5 (191 download)
Download or read book Analytical Testing for the Pharmaceutical GMP Laboratory written by Kim Huynh-Ba and published by John Wiley & Sons. This book was released on 2022-04-19 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author : Heather A. Wade
Publisher : Quality Press
ISBN 13 : 1636940218
Total Pages : 553 pages
Book Rating : 4.6/5 (369 download)
Download or read book The ASQ Metrology Handbook written by Heather A. Wade and published by Quality Press. This book was released on 2023-01-04 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ever-changing fields of science and technology have made huge leaps, thanks in part to improvements in measurements. Without metrology, these areas may not have experienced exponential growth. Developed by experts in the field as a comprehensive and practical reference, The ASQ Metrology Handbook, Third Edition provides a foundation for understanding metrology as well as calibration principles and practices. This handbook is ideal for not only metrology professionals, but also calibration professionals including calibration technicians and technologists, quality professionals, workers in testing laboratories, consultants, and instructors. Whether you are entering a new phase of your career field, investing in your own continuous improvement journey, training your fellow calibration practitioners, or preparing for ASQ’s Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals. New to this Third Edition: • A thorough explanation of ISO/IEC 17025:2017 • The 2019 Redefinition of the International System of Units • Updated and expanded chapters, including information about training and competency, software validation, statistics, decision rules and risk, uncertainty in measurement, mass and weighing, force, and chemical and biological measurements and uncertainties
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264304797
Total Pages : 206 pages
Book Rating : 4.2/5 (643 download)
Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Author : Anton Bespalov
Publisher : Springer Nature
ISBN 13 : 3030336565
Total Pages : 424 pages
Book Rating : 4.0/5 (33 download)
Download or read book Good Research Practice in Non-Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 : Robert McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 1782624074
Total Pages : 778 pages
Book Rating : 4.7/5 (826 download)
Download or read book Validation of Chromatography Data Systems written by Robert McDowall and published by Royal Society of Chemistry. This book was released on 2016-11-23 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
Author : R. D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 178801281X
Total Pages : 660 pages
Book Rating : 4.7/5 (88 download)
Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527335633
Total Pages : 451 pages
Book Rating : 4.5/5 (273 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 2014-11-10 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.
