Guideline on General Principles of Process Validation
| Author | : |
| Publisher | : |
| Total Pages | : 32 |
| Release | : 1987 |
| Genre | : Medical instruments and apparatus industry |
| ISBN | : |
Implementation Of A Cleaning Validation Program In A Multi Product Manufacturing Facility
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Handbook of Process Chromatography
| Author | : Gunter Jagschies |
| Publisher | : Elsevier |
| Total Pages | : 383 |
| Release | : 2007-12-08 |
| Genre | : Technology & Engineering |
| ISBN | : 0080554512 |
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
| Author | : John Geigert |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 365 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 144199131X |
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.
GAMP 5
| Author | : Sion Wyn |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2008 |
| Genre | : Computer systems |
| ISBN | : 9781931879613 |
GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Statistics for Censored Environmental Data Using Minitab and R
| Author | : Dennis R. Helsel |
| Publisher | : John Wiley & Sons |
| Total Pages | : 344 |
| Release | : 2012-02-01 |
| Genre | : Mathematics |
| ISBN | : 0470479884 |
Praise for the First Edition " . . . an excellent addition to an upper-level undergraduate course on environmental statistics, and . . . a 'must-have' desk reference for environmental practitioners dealing with censored datasets." —Vadose Zone Journal Statistics for Censored Environmental Data Using Minitab® and R, Second Edition introduces and explains methods for analyzing and interpreting censored data in the environmental sciences. Adapting survival analysis techniques from other fields, the book translates well-established methods from other disciplines into new solutions for environmental studies. This new edition applies methods of survival analysis, including methods for interval-censored data to the interpretation of low-level contaminants in environmental sciences and occupational health. Now incorporating the freely available R software as well as Minitab® into the discussed analyses, the book features newly developed and updated material including: A new chapter on multivariate methods for censored data Use of interval-censored methods for treating true nondetects as lower than and separate from values between the detection and quantitation limits ("remarked data") A section on summing data with nondetects A newly written introduction that discusses invasive data, showing why substitution methods fail Expanded coverage of graphical methods for censored data The author writes in a style that focuses on applications rather than derivations, with chapters organized by key objectives such as computing intervals, comparing groups, and correlation. Examples accompany each procedure, utilizing real-world data that can be analyzed using the Minitab® and R software macros available on the book's related website, and extensive references direct readers to authoritative literature from the environmental sciences. Statistics for Censored Environmental Data Using Minitab® and R, Second Edition is an excellent book for courses on environmental statistics at the upper-undergraduate and graduate levels. The book also serves as a valuable reference for??environmental professionals, biologists, and ecologists who focus on the water sciences, air quality, and soil science.
Continuous Manufacturing for the Modernization of Pharmaceutical Production
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 69 |
| Release | : 2019-04-05 |
| Genre | : Medical |
| ISBN | : 0309487811 |
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Clean-In-Place for Biopharmaceutical Processes
| Author | : Dale A. Seiberling |
| Publisher | : CRC Press |
| Total Pages | : 0 |
| Release | : 2007-10-15 |
| Genre | : Medical |
| ISBN | : 9780849340697 |
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.
Biopharmaceutical Processing
| Author | : Gunter Jagschies |
| Publisher | : Elsevier |
| Total Pages | : 1310 |
| Release | : 2018-01-18 |
| Genre | : Technology & Engineering |
| ISBN | : 0128125527 |
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
Good Design Practices for GMP Pharmaceutical Facilities
| Author | : Terry Jacobs |
| Publisher | : CRC Press |
| Total Pages | : 535 |
| Release | : 2016-08-19 |
| Genre | : Medical |
| ISBN | : 1482258919 |
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.
Pharmaceutical Manufacturing Handbook
| Author | : Shayne Cox Gad |
| Publisher | : John Wiley & Sons |
| Total Pages | : 1386 |
| Release | : 2008-03-11 |
| Genre | : Science |
| ISBN | : 0470259809 |
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.
