Good Clinical, Laboratory and Manufacturing Practices PDF Download

Author: Phillip A. Carson
Publisher: Royal Society of Chemistry
ISBN: 0854048340
Category : Science
Languages : en
Pages : 657

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Book Description
Provides practical advice for the quality assurance professional responsible for monitoring compliance with legal requirements and accepted standards of preclinical safety studies, clinical trials and manufacture of drugs. This book also offers a framework for integrating these standards with other quality management systems.

Author: E. Clyde Buchanan
Publisher: ASHP
ISBN: 1585283312
Category : Medical
Languages : en
Pages : 497

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Book Description
Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.

Author: John F. O'Hanlon
Publisher: John Wiley & Sons
ISBN: 1394174225
Category : Technology & Engineering
Languages : en
Pages : 580

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Book Description
A USERS GUIDE TO VACUUM TECHNOLOGY Choose and understand the vacuum technology that fits your project’s needs with this indispensable guide Vacuum technology is used to provide process environments for other kinds of engineering technology, making it an unsung cornerstone of hundreds of projects incorporating analysis, research and development, manufacturing, and more. Since it is very often a secondary technology, users primarily interested in processes incorporating it will frequently only encounter vacuum technology when purchasing or troubleshooting. There is an urgent need for a guide to vacuum technology made with these users in mind. For decades, A User’s Guide to Vacuum Technology has met this need, with a user-focused introduction to vacuum technology as it is incorporated into semiconductor, optics, solar sell, and other engineering processes. With an emphasis on otherwise neglected subjects and on accessibility to the secondary user of vacuum technology, it balances treatment of older systems that are still in use with a survey of the latest cutting-edge technologies. The result promises to continue as the essential guide to vacuum systems. Readers of the fourth edition of A User’s Guide to Vacuum Technology will also find: Expanded treatment of gauges, pumps, materials, systems, and best??operating practices Detailed discussion of cutting-edge topics like ultraclean vacuum and contamination control An authorial team with decades of combined research and engineering experience A User’s Guide to Vacuum Technology is essential for those entering emerging STEM programs, engineering professionals and graduate students working with a huge range of engineering technologies.

Author: Michael J. Groves
Publisher: CRC Press
ISBN: 1000122972
Category : Business & Economics
Languages : en
Pages : 542

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Book Description
Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

Author: American Institute of Architects
Publisher: John Wiley & Sons
ISBN: 111890950X
Category : Architecture
Languages : en
Pages : 1096

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Book Description
The 'Architect's Bible' since 1932, updated with the latest codes and standards Architectural Graphic Standards is the written authority for architects, designers, and building contractors. It provides comprehensive guidance on the visual representation of materials, products, systems, and assemblies. Updated to reflect the most current codes and standards, this new 12th edition features over 300 new drawings, tables, and designs and twenty-five percent new content. In response to architects' feedback and overwhelming demand for a more graphics-heavy format, this edition employs shorter, more accessible texts and more images of the standards and evolution of design and construction. New coverage includes building resiliency and the building envelope, expert discussion on the fundamentals of design and construction documentation, and new examination of environmental factors and material properties and performance. Sustainable Design is no longer separated, but incorporated throughout, and extensive appendices keep useful data right at your fingertips. Graphic standards are essential to building design. They cover everything from door frames and roof designs to air ducts and outdoor sports facilities. This meticulous resource provides a compendium of planning standards, optimum dimensions, and normative construction details. The book is organized into three core sections covering: design and documentation, materials, and building elements. Architectural Graphic Standards features: Key architectural design and production processes—functional planning, environmental assessment, building resiliency, and architectural construction documentation Thorough coverage of materials: concrete, masonry, metals, wood, plastics, composites, and glass An exhaustive survey of building elements—substructures, shells, services, equipment, furnishings, special structures, and siteworks Comprehensive appendixes filled with pertinent data such as: classic architectural elements, mathematical data, and structural calculations Endorsed by the American Institute of Architects, this book has an enduring and unsurpassed reputation for high-quality illustration, text, and graphic design. For crucial information in a user-friendly format, Architectural Graphic Standards is the go-to reference on building design and construction.

Author: Lt Col Pankaj Talwar VSM
Publisher: JAYPEE BROTHERS MEDICAL PUBLISHERS PVT. LTD.
ISBN: 9350259729
Category : Health & Fitness
Languages : en
Pages : 925

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Book Description
Manual of Assisted Reproductive Technologies and Clinical Embryology aims to discuss the relevance of science of reproductive biology in modern-day Assisted Reproductive Technologies and their practical applications. The readers can learn and master the large number of sophisticated techniques which form the backbone of the fascinating and growing field of human assisted reproduction. The subject is vast and has been covered over 83 chapters. All the chapters are dealt by the experts of concerned fields. Principles and protocols pertaining to laboratory maintenance, culture media, cryofreezing of gametes, embryos, and genital tissues have been dealt with at length. This book is an invaluable reference book for the clinicians, reproductive biologists and embryologists.

Author: Barbara Kanegsberg
Publisher: CRC Press
ISBN: 143982830X
Category : Science
Languages : en
Pages : 560

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Book Description
Applications, Processes, and Controls is the second volume in the Handbook for Critical Cleaning, Second Edition.Should you clean your product during manufacturing? If so, when and how? Cleaning is essential for proper performance, optimal quality, and increased sales. Inadequate cleaning of product elements can lead to catastrophic failure of the

Author: Thomas A. Barber
Publisher: CRC Press
ISBN: 1000065111
Category : Medical
Languages : en
Pages : 579

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Book Description
Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.

Author: Zhonglin Xu
Publisher: Springer Science & Business Media
ISBN: 3642393748
Category : Technology & Engineering
Languages : en
Pages : 871

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Book Description
Fundamentals of Air Cleaning Technology and Its Application in Cleanrooms sets up the theoretical framework for cleanrooms. New ideas and methods are presented, which include the characteristic index of cleanrooms, uniform and non-uniform distribution characteristics, the minimum sampling volume, a new concept of outdoor air conditioning and the fundamentals of leakage-preventing layers. Written by an author who can look back on major scientific achievements and 50 years of experience in this field, this book offers a concise and accessible introduction to the fundamentals of air cleaning technology and its application. The work is intended for researchers, college teachers, graduates, designers, technicians and corporate R&D personnel in the field of HVAC and air cleaning technology. Zhonglin Xu is a senior research fellow at China Academy of Building Research.

Author: Abraham Landzberg
Publisher: Springer Science & Business Media
ISBN: 1461520290
Category : Technology & Engineering
Languages : en
Pages : 663

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Book Description
The world of microelectronics is filled with cusses measurement systems, manufacturing many success stories. From the use of semi control techniques, test, diagnostics, and fail ure analysis. It discusses methods for modeling conductors for powerful desktop computers to their use in maintaining optimum engine per and reducing defects, and for preventing de formance in modem automobiles, they have fects in the first place. The approach described, clearly improved our daily lives. The broad while geared to the microelectronics world, has useability of the technology is enabled, how applicability to any manufacturing process of similar complexity. The authors comprise some ever, only by the progress made in reducing their cost and improving their reliability. De of the best scientific minds in the world, and fect reduction receives a significant focus in our are practitioners of the art. The information modem manufacturing world, and high-quality captured here is world class. I know you will diagnostics is the key step in that process. find the material to be an excellent reference in of product failures enables step func Analysis your application. tion improvements in yield and reliability. which works to reduce cost and open up new Dr. Paul R. Low applications and technologies. IBM Vice President and This book describes the process ofdefect re of Technology Products General Manager duction in the microelectronics world.