Guideline On Sterile Drug Products Produced By Aseptic Processing

Author : Center for Drugs and Biologics (U.S.)
Publisher :
ISBN 13 :
Total Pages : 48 pages
Book Rating : 4.41/5 ( download)

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Download or read book Guideline on Sterile Drug Products Produced by Aseptic Processing written by Center for Drugs and Biologics (U.S.) and published by . This book was released on 1987 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher :
ISBN 13 :
Total Pages : 59 pages
Book Rating : 4.55/5 ( download)

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Download or read book Guidance for industry written by and published by . This book was released on 2004 with total page 59 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : United States Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 43 pages
Book Rating : 4.81/5 ( download)

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Download or read book Guidelines on Sterile Drug Products Produced by Aseptic Processing written by United States Food and Drug Administration and published by . This book was released on 1993 with total page 43 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Sam A. Hout
Publisher : CRC Press
ISBN 13 : 1000406121
Total Pages : 148 pages
Book Rating : 4.22/5 ( download)

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Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-04 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : James Agalloco
Publisher : CRC Press
ISBN 13 : 1439825440
Total Pages : 495 pages
Book Rating : 4.40/5 ( download)

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Download or read book Advanced Aseptic Processing Technology written by James Agalloco and published by CRC Press. This book was released on 2016-04-19 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

Author : Michael J. Groves
Publisher : CRC Press
ISBN 13 : 9780935184778
Total Pages : 544 pages
Book Rating : 4.75/5 ( download)

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Download or read book Aseptic Pharmaceutical Manufacturing II written by Michael J. Groves and published by CRC Press. This book was released on 1995-05-31 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Michael J. Akers
Publisher : CRC Press
ISBN 13 : 1420020560
Total Pages : 517 pages
Book Rating : 4.64/5 ( download)

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Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This

Author : Sam A. Hout
Publisher : CRC Press
ISBN 13 : 1000406091
Total Pages : 206 pages
Book Rating : 4.92/5 ( download)

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Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-05 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : W. Whyte
Publisher : John Wiley & Sons
ISBN 13 : 9780471868422
Total Pages : 336 pages
Book Rating : 4.26/5 ( download)

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Download or read book Cleanroom Technology written by W. Whyte and published by John Wiley & Sons. This book was released on 2001-10-17 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with an introduction to this state-of-the-art technology and professionals with an accessible reference to current standards.

Author : Byron Lambert
Publisher : Academic Press
ISBN 13 : 0128050829
Total Pages : 266 pages
Book Rating : 4.28/5 ( download)

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Download or read book Assurance of Sterility for Sensitive Combination Products and Materials written by Byron Lambert and published by Academic Press. This book was released on 2019-06-15 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. Introduces sterilization principles at the material selection and design stages Addresses the industry need for new sterilization processes for new medical devices and biomaterials Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies