Download or read book Facility Validation written by Graham C. Wrigley and published by CRC Press. This book was released on 2004-03-29 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explo
Download or read book Pharmaceutical Facilities written by Manohar A Potdar and published by . This book was released on 2014-11 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry. Salient Features: - Pharmaceutical design aspects with sample layouts for all major formulations are discussed - All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed - A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.
Download or read book Planning and Designing Research Animal Facilities written by Jack Hessler and published by Academic Press. This book was released on 2011-04-28 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research institutions have or are planning to build, expand and renovate animal research facilities to keep up with the demands of biomedical research caused in part by growth in the use of genetically altered rodents and the upsurge of research in infectious diseases. Properly designed facilities greatly facilitate effective management and high-quality day-to-day animal care that is required to optimally support animal research and testing. There are multiple solutions to address the myriad of factors that influence the design and construction of animal research facilities. There is no “best design applicable for all facilities and arguably not even a single “best design for a given facility. For this reason, Planning and Designing Research Animal Facilities is not intended to be a “how to book. The goal is to cover the basic programmatic requirements of animal research facilities, provide ideas for meeting those requirements while, hopefully, stimulating the creative process in which designers in consultation with those who work in animal research facilities generate even better ideas. That is how progress has been made and will continue to be made. Facilitates communication between the parties involved in planning and designing animal facilities by providing contemporary information, and stimulating creativity that will help lead to wise decisions and advance the knowledge base for planning, design and constructing animal research facilities
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 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 Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 509 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Download or read book DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
Download or read book Technology Commercialization Manual written by Melvin Joseph DeGeeter and published by Med-Launch, Inc.. This book was released on 2004 with total page 726 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
Download or read book Validation of Food Preservation Processes based on Novel Technologies written by Tatiana Koutchma and published by Academic Press. This book was released on 2021-11-30 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of Food Preservation Processes based on Novel Technologies discusses and recommends activities for bench top, pilot, prototype and commercial high hydrostatic pressure (HPP) and ultraviolet (UV) systems validation. The book explores issues of equipment scalability, selection of microorganisms of concern and their surrogates, validation and verification of critical processing conditions, treatment uniformity, process control and instrumentation. Topics are discussed in order to facilitate HPP and UV technologies implementation, thus mitigating risks during production and processing. Other sections deal with the selection of suitable surrogates that can be used in validation studies and procedures for their selection. The book also encloses case studies of validation of UV and HPP systems for pathogen reduction in juice. Edited by the main experts in the field of non-thermal food processing, this title is a guide for food process developers from starting to final point of the development and validation. Brings science-based validation practices for food processes using novel preservation technologies Guides food process developers from starting point to final point of development and validation Explains objectives of the process development on each stage, including in-lab, pilot scale and commercialization
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Gail Sofer and published by CRC Press. This book was released on 2000-03-24 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness wh
Download or read book Process Validation in Manufacturing of Biopharmaceuticals Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
Download or read book Cleaning and Cleaning Validation written by Jon Voss and published by Routledge. This book was released on 2018-05-04 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a source of practical, technicalinformation for those persons in the biotechnology industry. Casestudies and/ or actual industry examples are used to support the textwherever possible. While much of the material contained within thistext is equally applicable to nonbiopharmaceutical processes, theemphasis has been focused directly upon biopharmaceuticalmanufacturing.Section I provides an in-depth analysis of the design concepts thatlead to cleanable equipment. Also covered in the tirst section arecleaning mechanisms and cleaning systems. The first section isparticularly useful to those persons faced with the task of designingsystems that will be cleaned and also provides the biochemicaloockground of the mechanisms associated with the removal of commonbiotechnology soils.Section II focuses on cleaning validation concepts. While thematerial is equally useful for single product cleaning, emphasis isplaced upon multiproduct cleaning validation. Included in Section IIare general validation principles as thex apply to cleaning validation,detailed analxsis of cleaning process validation, sampling techniques,analytical methods and acceptance criteria. The material in this sectionwill be useful to anyone responsible for the development of a cleaningvalidation program.The final section, Section Ill, provides an overview of multiproductbiotechnology manufacturing procedures. Included in this section is ananalysis of tne risk-to-benefit scenarios associated with the various formsof product manufacturing, analysis of changeover programs, ~uipmentconsiderations, and material transfer systems as they are affected bymultiproduct manufacturing strategies.
Download or read book Advances in Building Technology written by M. Anson and published by Elsevier. This book was released on 2002-11-14 with total page 1844 pages. Available in PDF, EPUB and Kindle. Book excerpt: This set of proceedings is based on the International Conference on Advances in Building Technology in Hong Kong on 4-6 December 2002. The two volumes of proceedings contain 9 invited keynote papers, 72 papers delivered by 11 teams , and 133 contributed papers from over 20 countries around the world. The papers cover a wide spectrum of topics across the three technology sub-themes of structures and construction, environment, and information technology. The variety within these categories spans a width of topics, and these proceedings provide readers with a good general overview of recent advances in building research.
Download or read book Validation Compliance Annual written by International Validation Forum and published by CRC Press. This book was released on 1995-02-17 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."
Download or read book Validation Practices for Biotechnology Products written by J. K. Shillenn and published by ASTM International. This book was released on 1996 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the current methods and practices by which companies that produce genetically altered drugs assure that all components and finished products have the identity, strength, quality, and purity that is purported and represented. Also considers possible improvements and whether industry standard
