Download or read book The Design Construction and Commissioning of a New Facility in Accordance with GMP Regulations written by Paul L. Simmons and published by . This book was released on 1987 with total page 708 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 Process Architecture in Biomanufacturing Facility Design written by Jeffery Odum and published by John Wiley & Sons. This book was released on 2017-11-03 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
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 Sterile Product Facility Design and Project Management written by Jeffrey N. Odum and published by CRC Press. This book was released on 1996-11-01 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and construction of a sterile product facility for the manufacture of pharmaceuticals is a complex undertaking that involves many considerations not typically encountered when building more traditional pharmaceutical facilities. Focusing on proven fundamentals, this book explains the unique facility design needs of sterile product manufacturing. Containing numerous charts, graphs, tables, and sample forms, the author covers sterile facility design and project management from A to Z. Topics include: project formation, defining the project team, facility programming, project control and costing, and GMP requirements and their impact on architectural design and construction.
Download or read book Commissioning Qualification and Validation written by Priscilla Browne and published by Createspace Independent Publishing Platform. This book was released on 2017-06 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Commissioning, Qualification and Validation (CQV) are requirements of modern facilities within the Life Science industry. Be it a Medical Device Manufacturing, pharmaceuticals or bio-pharmaceuticals, each present challenges in how new facilities, equipment, utilities and processes are introduced. Providing a defined approach to CQV aligns activities to ensure success and the timely completion. This book covers the core elements of CQV including the key steps, terminology and how an integrated approach to CQV can be achieved. Chapter 1-Introduction to Commissioning & Qualification (C&Q) Chapter 2-Facilities Chapter 3-Introduction to Validation Chapter 4-Design Requirement Chapter 5-Risk Management Chapter 6-Validation Planning Chapter 7-Clean Utilities Chapter 8-Equipment Validation Chapter 9-Process Validation Chapter 10-Test Method Validation Chapter 11-Supplier Validation Chapter 12-Summary of Good Manufacturing Practices (GMP)
Download or read book Cell Therapy written by Adrian Gee and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.
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.
Download or read book Fundamentals of Building Construction written by Edward Allen and published by John Wiley & Sons. This book was released on 2019-10-15 with total page 944 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE #1 REFERENCE ON BUILDING CONSTRUCTION—UPDATED FROM THE GROUND UP Edward Allen and Joseph Iano’s Fundamentals of Building Construction has been the go-to reference for thousands of professionals and students of architecture, engineering, and construction technology for over thirty years. The materials and methods described in this new Seventh Edition have been thoroughly updated to reflect the latest advancements in the industry. Carefully selected and logically arranged topics—ranging from basic building methods to the principles of structure and enclosure—help readers gain a working knowledge of the field in an enjoyable, easy-to-understand manner. All major construction systems, including light wood frame, mass timber, masonry, steel frame, light gauge steel, and reinforced concrete construction, are addressed. Now in its Seventh Edition, Fundamentals of Building Construction contains substantial revisions and updates. New illustrations and photographs reflect the latest practices and developments in the industry. Revised chapters address exterior wall systems and high-performance buildings, an updated and comprehensive discussion of building enclosure science, evolving tools for assessing environmental and health impacts of building materials, and more. New and exciting developments in mass timber construction are also included. This Seventh Edition includes: 125 new or updated illustrations and photographs, as well as 40 new photorealistic renderings The latest in construction project delivery methods, construction scheduling, and trends in information technology affecting building design and construction Updated discussion of the latest LEED and Living Building Challenge sustainability standards along with expanded coverage of new methods for assessing the environmental impacts of materials and buildings Expanded coverage of mass timber materials, fire resistance of mass timber, and the design and construction of tall wood buildings Revised end-of-chapter sections, including references, websites, key terminology, review questions, and exercises Fully-updated collection of best-in-class ancillary materials: PowerPoint lecture slides, Instructor’s Manual, Test Bank, Interactive Exercises, and more Companion book, Exercises in Building Construction, available in print and eBook format For the nuts and bolts on building construction practices and materials, Fundamentals of Building Construction: Materials and Methods, 7th Edition lays the foundation that every architect and construction professional needs to build a successful career.
Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2015-03-20 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
Download or read book Sterile Product Facility Design and Project Management written by Jeffrey N. Odum and published by CRC Press. This book was released on 2004-03-29 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provid
Download or read book Process Plant Commissioning written by D. M. C. Horsley and published by IChemE. This book was released on 1998 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook on the commissioning of all process plants, large and small, has been fully updated and expanded. The aim of the text is to provide the non-specialist with advice on how to set about the problem of commissioning either a new plant or a modification. Some aspects of decommissioning are also included. The section on legislation has been expanded and updated to cover all areas of safety, health and environment.
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 Facilities Staffing Requirements for the Veterans Health Administration Resource Planning and Methodology for the Future written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-30 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Veterans Health Administration (VHA) is America's largest integrated health care system, providing care at 1,243 health care facilities, including 172 medical centers and 1,063 outpatient sites of care of varying complexity, serving 9 million enrolled Veterans each year. In addition, VHA has opened outpatient clinics and established telemedicine and other services to accommodate a diverse veteran population and continues to cultivate ongoing medical research and innovation. Facilities specific to VHA fulfill clinical, operational, research laboratory, and administrative functions. Each site is designed to serve a geographical location with specific health care needs. VHA's building inventory has sites of different ages, and often there is a mix of building size and age at each site or campus. At the request of the VHA, this study presents a comprehensive resource planning and staffing methodology guidebook for VHA Facility Management Programs by reviewing the tasks of VHA building facilities staff and recommending actions for the VHA to meet the mission goals of delivering patient care, research, and effective operations.
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 Real Project Planning Developing a Project Delivery Strategy written by Trish Melton and published by Butterworth-Heinemann. This book was released on 2011-04-08 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful projects are the basis for a successful company, but many professionals lack the basic skills required to accomplish this. The IChemE Project Management Subject Group has recognized the need to provide resources to deliver these skills, and has developed a series of books to share the latest best practice – engineering essentials. This second title, though primarily written from the perspective of engineering projects within the process industries, is generic enough to support project managers in many other disciplines. It provides for those starting out in project management, is ideal for students as a university textbook, and is also an indispensable reference for established project managers. - Get up and running on your project quickly and effectively - Focuses one step at a time on the needs of engineering, industrial and process projects for career project managers and those involved with projects intermittently
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
