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Author :International Society for Pharmaceutical Engineering Publisher : ISBN 13 :9781936379149 Total Pages :200 pages Book Rating :4.3/5 (791 download)
Book Synopsis Sterile Product Manufacturing Facilities by : International Society for Pharmaceutical Engineering
Download or read book Sterile Product Manufacturing Facilities written by International Society for Pharmaceutical Engineering and published by . This book was released on 2011 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis ISPE Baseline® Guide: Volume 3 - Sterile Product Manufacturing Facilities by : Ispe
Download or read book ISPE Baseline® Guide: Volume 3 - Sterile Product Manufacturing Facilities written by Ispe and published by . This book was released on 2011-10-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2018-04-25 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2010-01-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterile Manufacturing Facilities by : ISPE
Download or read book Sterile Manufacturing Facilities written by ISPE and published by . This book was released on 1999-01-01 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2010-03-24 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Baseline Pharmaceutical Engineering Guide by :
Download or read book Baseline Pharmaceutical Engineering Guide written by and published by . This book was released on 1999 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Baseline Pharmaceutical Engineering Guide: Sterile manufacturing facilities by :
Download or read book Baseline Pharmaceutical Engineering Guide: Sterile manufacturing facilities written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical Engineering Guides for New and Renovated Facilities by : ISPE
Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by ISPE and published by . This book was released on 2004-06-01 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sterile Manufacturing Facilities by : International Society of Pharmaceutical Engineers
Download or read book Sterile Manufacturing Facilities written by International Society of Pharmaceutical Engineers and published by . This book was released on 1999 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical Engineering Guides for New and Renovated Facilities by :
Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by and published by . This book was released on 1996 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Book Synopsis Sterile Manufacturing by : Sam A. Hout
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.
Book Synopsis Handbook for Critical Cleaning: Applications, processes, and controls by : Barbara Kanegsberg
Download or read book Handbook for Critical Cleaning: Applications, processes, and controls written by Barbara Kanegsberg and published by CRC Press. This book was released on 2011 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nearly all companies which manufacture or fabricate high-value physical objects (components, parts, assemblies) perform critical cleaning at one or more stages. These range from the giants of the semiconductor, aerospace, and biomedical world to a host of small to medium to large companies producing a dizzying array of components"--
Book Synopsis Good Design Practices for GMP Pharmaceutical Facilities by : Terry Jacobs
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Book Synopsis Handbook of Validation in Pharmaceutical Processes, Fourth Edition by : James Agalloco
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 ISPE Baseline® Guide written by Ispe and published by . This book was released on 2010-01-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
