Download or read book ISPE Good Practice Guide Commissioning and Qualification of Pharmaceutical Water and Steam Systems written by Ispe and published by . This book was released on 2009-04-15 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2014-07-23 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Commissioning and Qualification of Pharmaceutical Water and Steam Systems written by and published by Ispe. This book was released on 2007-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book ISPE Guide written by International Society for Pharmaceutical Engineering and published by . This book was released on 2011 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-03-25 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2005-09-05 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Microbial Limit and Bioburden Tests written by Lucia Clontz and published by CRC Press. This book was released on 2008-10-14 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c

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 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.

Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Rules of Thumb for Chemical Engineers written by Carl Branan and published by Gulf Professional Publishing. This book was released on 2002 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fractionators, separators and accumulators, cooling towers, gas treating, blending, troubleshooting field cases, gas solubility, and density of irregular solids * Hundreds of common sense techniques, shortcuts, and calculations.

Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2006-05-30 with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Practical Fermentation Technology written by Brian McNeil and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: A hands-on book which begins by setting the context;- defining 'fermentation' and the possible uses of fermenters, and setting the scope for the book. It then proceeds in a methodical manner to cover the equipment for research scale fermentation labs, the different types of fermenters available, their uses and modes of operation. Once the lab is equipped, the issues of fermentation media, preservation strains and strain improvement strategies are documented, along with the use of mathematical modelling as a method for prediction and control. Broader questions such as scale-up and scale down, process monitoring and data logging and acquisition are discussed before separate chapters on animal cell culture systems and plant cell culture systems. The final chapter documents the way forward for fermenters and how they can be used for non-manufacturing purposes. A glossary of terms at the back of the book (along with a subject index) will prove invaluable for quick reference.Edited by academic consultants who have years of experience in fermentation technology, each chapter is authored by experts from both industry and academia. Industry authors come from GSK (UK), DSM (Netherlands), Eli Lilly (USA) and Broadley James (UK-USA).