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Author : Daniel Farb, M.D.
Publisher : Universityofhealthcare
ISBN 13 : 9781594910265
Total Pages : 258 pages
Book Rating : 4.9/5 (12 download)
Download or read book GMP Training Package, Manual and CD written by Daniel Farb, M.D. and published by Universityofhealthcare. This book was released on 2003-12-01 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : C.Th. Smit Sibinga
Publisher : Springer Science & Business Media
ISBN 13 : 9780792330097
Total Pages : 328 pages
Book Rating : 4.3/5 (3 download)
Download or read book Good Manufacturing Practice in Transfusion Medicine written by C.Th. Smit Sibinga and published by Springer Science & Business Media. This book was released on 1994-08-31 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of the Eighteenth International Symposium on Blood Transfusion, Groningen 1993, organized by the Red Cross Blood Bank Groningen-Drenthe
Author : Joseph D. Nally
Publisher : CRC Press
ISBN 13 : 1420020935
Total Pages : 418 pages
Book Rating : 4.4/5 (2 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Author : Manohar A Potdar
Publisher : Pharmamed Press
ISBN 13 : 9789387593442
Total Pages : 856 pages
Book Rating : 4.5/5 (934 download)
Download or read book CGMP Current Good Manufacturing Practices for Pharmaceuticals written by Manohar A Potdar and published by Pharmamed Press. This book was released on 2019-07 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner.
Author : Vesper
Publisher : David Horwood International Pub Limited
ISBN 13 : 9781930114173
Total Pages : 224 pages
Book Rating : 4.1/5 (141 download)
Download or read book GMP in Practice written by Vesper and published by David Horwood International Pub Limited. This book was released on 2000-07 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Graham P. Bunn
Publisher : CRC Press
ISBN 13 : 1351646990
Total Pages : 334 pages
Book Rating : 4.3/5 (516 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals, Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 143985016X
Total Pages : 484 pages
Book Rating : 4.4/5 (398 download)
Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences
Author : José Rodríguez-Pérez
Publisher : Quality Press
ISBN 13 : 0873898699
Total Pages : 246 pages
Book Rating : 4.8/5 (738 download)
Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author : Mark Allen Durivage
Publisher : Quality Press
ISBN 13 : 1951058909
Total Pages : 404 pages
Book Rating : 4.9/5 (51 download)
Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Author : John Geigert
Publisher : Springer
ISBN 13 : 3030137546
Total Pages : 446 pages
Book Rating : 4.0/5 (31 download)
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Author : Adrian Gee
Publisher : Springer Science & Business Media
ISBN 13 : 0387895841
Total Pages : 258 pages
Book Rating : 4.3/5 (878 download)
Download or read book Cell Therapy written by Adrian Gee and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.
Author : Kim Huynh-Ba
Publisher : John Wiley & Sons
ISBN 13 : 1119680433
Total Pages : 420 pages
Book Rating : 4.1/5 (196 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 2022-03-31 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 : C.Th. Smit Sibinga
Publisher : Springer Science & Business Media
ISBN 13 : 1461526086
Total Pages : 293 pages
Book Rating : 4.4/5 (615 download)
Download or read book Good Manufacturing Practice in Transfusion Medicine written by C.Th. Smit Sibinga and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: TQM AND TAYLORISM; HOW THEY COMPARE H. Bremer Preface The industrial world today is divided between two camps: a culture based on the principles of Total Quality Management (TQM), developed in the Far East, and one still strongly influenced by the origins of "Scientific Management", intro duced in the West by F.W. Taylor and others at the turn of the century. This divergence will be shown to have arisen in the last forty years, long enough for a new generation of managers and corresponding culture to emerge. The two cul tures are so deeply entrenched that it is difficult for one to change to the other. However, there is strong evidence to support the contention that people-oriented TQM is superior, and those companies clinging to Taylor models now face diffi cult decisions. Actions by Taylor-companies to move to TQM rnight weH be hindered rather than helped by applying present Quality Assurance Standards, developed by Taylor-oriented national and international Standards Institutions.
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 : Institute of Food Science and Technology
Publisher : John Wiley & Sons
ISBN 13 : 1118318234
Total Pages : 277 pages
Book Rating : 4.1/5 (183 download)
Download or read book Food and Drink - Good Manufacturing Practice written by Institute of Food Science and Technology and published by John Wiley & Sons. This book was released on 2012-11-26 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) refers to advice and guidance put in place to outline the aspects of production and testing that can impact the quality and safety of a product. In the case of food and drink, GMP is aimed at ensuring that products are safe for the consumer and are consistently manufactured to a quality appropriate to their intended use. Manufacturers have for several years been driving towards such goals as Total Quality Management (TQM), lean manufacturing and sustainability – GMP is bound up with these issues. The ever-increasing interest amongst consumers, retailers and enforcement authorities in the conditions and practices in food manufacture and distribution, increases the need for the food manufacturer to operate within clearly defined policies such as those laid down in GMP. The ability to demonstrate that Good Manufacturing Practice has been fully and effectively implemented could, in the event of a consumer complaint or a legal action, reduce the manufacturer’s liability and protect them from prosecution. First launched in 1986, IFST’s Good Manufacturing Practice Guide has been widely recognized as an indispensable reference work for food scientists and technologists. It sets out to ensure that food manufacturing processes deliver products that are uniform in quality, free from defects and contamination, and as safe as it is humanly possible to make them. This 6th edition has been completely revised and updated to include all the latest standards and guidance, especially with regard to legislation-driven areas such as HACCP. The Guide is a must have for anyone in a managerial or technical capacity concerned with the manufacture, storage and distribution of food and drink. It is also a valuable reference for food education, training and for those involved in food safety and enforcement. Food scientists in academic and industry environments will value its precision, and policy makers and regulatory organizations will find it an indispensable guide to an important and multifaceted area. About IFST IFST is the leading independent qualifying body for food professionals in Europe and the only professional body in the UK concerned with all aspects of food science and technology. IFST members are drawn from all over the world and from all ages and backgrounds, including industry (manufacturing, retailing and food service), universities and schools, government, research and development, quality assurance and food law enforcement. IFST qualifications are internationally recognised as a sign of proficiency and integrity.
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
ISBN 13 : 9780982147603
Total Pages : 686 pages
Book Rating : 4.1/5 (476 download)
Download or read book Good Manufacturing Practice (GMP) Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author : Thomas Catalano
Publisher : Springer Science & Business Media
ISBN 13 : 1461476429
Total Pages : 203 pages
Book Rating : 4.4/5 (614 download)
Download or read book Essential Elements for a GMP Analytical Chemistry Department written by Thomas Catalano and published by Springer Science & Business Media. This book was released on 2013-06-20 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies.
