Download or read book Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.
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 ISPE Good Practice Guide Heating Ventilation and Air Conditioning HVAC written by Ispe and published by . This book was released on 2013-07-18 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Instrument Engineers Handbook Volume 3 written by Bela G. Liptak and published by CRC Press. This book was released on 2018-10-08 with total page 1140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Instrument Engineers' Handbook – Volume 3: Process Software and Digital Networks, Fourth Edition is the latest addition to an enduring collection that industrial automation (AT) professionals often refer to as the "bible." First published in 1970, the entire handbook is approximately 5,000 pages, designed as standalone volumes that cover the measurement (Volume 1), control (Volume 2), and software (Volume 3) aspects of automation. This fourth edition of the third volume provides an in-depth, state-of-the-art review of control software packages used in plant optimization, control, maintenance, and safety. Each updated volume of this renowned reference requires about ten years to prepare, so revised installments have been issued every decade, taking into account the numerous developments that occur from one publication to the next. Assessing the rapid evolution of automation and optimization in control systems used in all types of industrial plants, this book details the wired/wireless communications and software used. This includes the ever-increasing number of applications for intelligent instruments, enhanced networks, Internet use, virtual private networks, and integration of control systems with the main networks used by management, all of which operate in a linked global environment. Topics covered include: Advances in new displays, which help operators to more quickly assess and respond to plant conditions Software and networks that help monitor, control, and optimize industrial processes, to determine the efficiency, energy consumption, and profitability of operations Strategies to counteract changes in market conditions and energy and raw material costs Techniques to fortify the safety of plant operations and the security of digital communications systems This volume explores why the holistic approach to integrating process and enterprise networks is convenient and efficient, despite associated problems involving cyber and local network security, energy conservation, and other issues. It shows how firewalls must separate the business (IT) and the operation (automation technology, or AT) domains to guarantee the safe function of all industrial plants. This book illustrates how these concerns must be addressed using effective technical solutions and proper management policies and practices. Reinforcing the fact that all industrial control systems are, in general, critically interdependent, this handbook provides a wide range of software application examples from industries including: automotive, mining, renewable energy, steel, dairy, pharmaceutical, mineral processing, oil, gas, electric power, utility, and nuclear power.
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 2018-01-26 with total page 381 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 Perinatal Tissue Derived Stem Cells written by Babak Arjmand and published by Springer. This book was released on 2016-12-01 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers several aspects of perinatal tissue-derived stem cells, from theoretical concepts to clinical applications. Topics include functions and different sources, immunomodulatory properties, translational point of view, GMP facility design and manufacturing for clinical translation, therapeutic potentials, and finally ethical considerations. The text provides a brief review of each type of perinatal stem cells and then focuses on their multi- or pluripotent properties, regenerative capacity, and future therapeutic potential in regenerative medicine. Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation. The chapters are authored by world-renowned experts in the perinatal stem cell field. Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for basic and clinical scientists, clinicians, and pharmaceutical experts working or conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, and cellular therapy.
Download or read book Quality assurance of pharmaceuticals a compendium of guidelines and related materials Volume 2 Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2019-05-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.
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 Veterinary Vaccines written by Samia Metwally and published by John Wiley & Sons. This book was released on 2021-04-01 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a concise and authoritative reference on the use of vaccines against diseases of livestock Compiled by Senior Animal Health Officers at The Food and Agriculture Organization of the United Nations, and with contributions from international leading experts, Veterinary Vaccines: Principles and Applications is a concise and authoritative reference featuring easily readable reviews of the latest research in vaccinology and vaccine immune response to pathogens of major economic impact to livestock. It covers advice and recommendations for vaccine production, quality control, and effective vaccination schemes including vaccine selection, specifications, vaccination programs, vaccine handling in the field, application, failures, and assessment of herd protection. In addition, the book presents discussions on the current status and potential future developments of vaccines and vaccination against selected transboundary animal diseases. Provides a clear and comprehensive guide on using veterinary vaccines to protect livestock from diseases Teaches the principles of vaccinology and vaccine immune response Highlights the vaccine production schemes and standards for quality control testing Offers easy-to-read reviews of the most current research on the subject Gives readers advice and recommendations on which vaccination schemes are most effective Discusses the today’s state of vaccines and vaccination against selected transboundary animal diseases as well as possible future developments in the field Veterinary Vaccines: Principles and Applications is an important resource for veterinary practitioners, animal health department officials, vaccine scientists, and veterinary students. It will also be of interest to professional associations and NGO active in livestock industry.
Download or read book Guidelines for Laboratory Design written by Louis J. DiBerardinis and published by John Wiley & Sons. This book was released on 2013-04-08 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proven and tested guidelines for designing ideal labs for scientific investigations Now in its Fourth Edition, Guidelines for Laboratory Design continues to enable readers to design labs that make it possible to conduct scientific investigations in a safe and healthy environment. The book brings together all the professionals who are critical to a successful lab design, discussing the roles of architects, engineers, health and safety professionals, and laboratory researchers. It provides the design team with the information needed to ask the right questions and then determine the best design, while complying with current regulations and best practices. Guidelines for Laboratory Design features concise, straightforward advice organized in an easy-to-use format that facilitates the design of safe, efficient laboratories. Divided into five sections, the book records some of the most important discoveries and achievements in: Part IA, Common Elements of Laboratory Design, sets forth technical specifications that apply to most laboratory buildings and modules Part IB, Common Elements of Renovations, offers general design principles for the renovation and modernization of existing labs Part II, Design Guidelines for a Number of Commonly Used Laboratories, explains specifications, best practices, and guidelines for nineteen types of laboratories, with three new chapters covering nanotechnology, engineering, and autopsy labs Part III, Laboratory Support Services, addresses design issues for imaging facilities, support shops, hazardous waste facilities, and laboratory storerooms Part IV, HVAC Systems, explains how to heat, cool, and ventilate labs with an eye towards energy conservation Part V, Administrative Procedures, deals with bidding procedures, final acceptance inspections, and sustainability The final part of the book features five appendices filled with commonly needed data and reference materials. This Fourth Edition is indispensable for all laboratory design teams, whether constructing a new laboratory or renovating an old facility to meet new objectives.
Download or read book Practical Guide to Single use Technology written by Adriana G Lopes and published by Smithers Rapra. This book was released on 2016-08-31 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2019-12-02 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
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 Pharmaceutical Production written by Bill Bennett and published by IChemE. This book was released on 2003 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title is a general introduction aimed at all those involved in the engineering stages required for the manufacturr of the active ingredient and its dosage forms.
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 ISPE Good Practice Guide written by and published by . This book was released on 2009 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
