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:
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.
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.
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:
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.
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.
Download or read book Testing Computers Systems for FDA MHRA Compliance written by David Stokes and published by CRC Press. This book was released on 2003-11-25 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an
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.
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.
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:
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 ...
Download or read book Handbook of Validation in Pharmaceutical Processes Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Download or read book Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
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
Download or read book Health Care Management and the Law written by Donna K. Hammaker and published by Jones & Bartlett Learning. This book was released on 2017-03-02 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health Care Management and the Law-2nd Edition is a comprehensive practical health law text relevant to students seeking the basic management skills required to work in health care organizations, as well as students currently working in health care organizations. This text is also relevant to those general health care consumers who are simply attempting to navigate the complex American health care system. Every attempt is made within the text to support health law and management theory with practical applications to current issues.
Download or read book International IT Regulations and Compliance written by Siri H. Segalstad and published by John Wiley & Sons. This book was released on 2008-11-20 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.
Download or read book Drugs written by Rick Ng and published by John Wiley & Sons. This book was released on 2015-04-28 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prozesse, die für die Marktreife von Medikamenten erforderlich sind. Behandelt werden unter anderem vorklinische Studien, klinische Studien am Menschen, regulatorische Kontrollen und sogar die Herstellungsprozesse von pharmazeutischen Produkten. Nach einen prägnanten und leicht verständlichen Vorstellung der grundlegenden Konzepte werden die Zielstrukturen und der Entwicklungsprozess von klein- und großmolekularen Arzneimittel präsentiert. In der 3. aktualisiertenAuflage ist dieses Fachbuch noch ansprechender. Neben den neuesten Entwicklungen werden die einzelnen Themen noch umfassender erläutert und durch zusätzliche Materialien und Fallstudien für den Einsatz an Hochschulen und Universitäten ergänzt. Die Biotechnologie ist ein dynamisches Fachgebiet. Forschung und Entwicklung, klinische Prüfungen, Herstellungsverfahren und regulatorische Prozesse unterliegen ständigen Veränderungen. Biotechnologie und Biowissenschaften sind vom globalem Interesse. Daher besetzt dieses Fachbuch eine Nische und erhält immer wieder gute Kritiken. Die überarbeitete 3. Auflage sorgt für anhaltende Relevanz und Nutzen für die Leser.
