Download or read book How to Sell Validatable Equipment to Pharmaceutical Manufacturers written by Erik Kopp and published by CRC Press. This book was released on 1999-09-30 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner. Key areas of discussion include: o Validation and GMP issues o Why validation is so important to pharmaceutical manufacturers o The role of equipment suppliers in supporting validation o How validation affects the quality of drugs o A discussion of the importance of each phase of validation o Examples of pre-validation work o Pharmaceutical industry conventions for equipment design & construction o Questions to ask about validation, including a checklist o Regulations in plain language, including the terms and vocabulary o Computer validation o Business & cost issues
Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary. Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.
Download or read book Forthcoming Books written by Rose Arny and published by . This book was released on 2000 with total page 1356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book American Book Publishing Record written by and published by . This book was released on 2000 with total page 1886 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Subject Guide to Books in Print written by and published by . This book was released on 1997 with total page 3310 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 674 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.
Download or read book Animal Cell Technology From Target to Market written by E. Lindner-Olsson and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of the 17th ESACT Meeting June 10-14, 2001, Tylösand, Sweden
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-21 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Download or read book Book Review Index written by and published by . This book was released on 2003 with total page 1520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. 8-10 of the 1965-1984 master cumulation constitute a title index.
Download or read book Clean In Place for Biopharmaceutical Processes written by Dale A. Seiberling and published by CRC Press. This book was released on 2007-10-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.
Download or read book Books in Print Supplement written by and published by . This book was released on 2002 with total page 2576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Thomas Register of American Manufacturers written by and published by . This book was released on 2003 with total page 2142 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. for 1970-71 includes manufacturers catalogs.
Download or read book Aseptic Pharmaceutical Manufacturing II written by Michael J. Groves and published by CRC Press. This book was released on 2020-08-14 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.
Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1308 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Download or read book Thomas Register of American Manufacturers and Thomas Register Catalog File written by and published by . This book was released on 2002 with total page 1878 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. for 1970-71 includes manufacturers' catalogs.
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.
