Handbook of Validation in Pharmaceutical Processes, Fourth Edition PDF Download

Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062

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Book Description
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

Author: Barbara Kanegsberg
Publisher: CRC Press
ISBN: 1466515945
Category : Science
Languages : en
Pages : 1109

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Book Description
This set consists of two volumes: Cleaning Agents and Systems and Applications, Processes, and Controls. Updated, expanded, re-organized, and rewritten, this two-volume handbook covers cleaning processes, applications, management, safety, and environmental concerns. The editors rigorously examine technical issues, cleaning agent options and systems, chemical and equipment integration, and contamination control, as well as cleanliness standards, analytical testing, process selection, implementation and maintenance, specific application areas, and regulatory issues. A collection of international contributors gives the text a global viewpoint. Color illustrations, video clips, and animation are available online to help readers better understand presented material.

Author: Michael Ljungberg
Publisher: CRC Press
ISBN: 0429952104
Category : Medical
Languages : en
Pages : 374

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Book Description
This state-of-the-art handbook, the third and final in a series that provides medical physicists with a comprehensive overview into the field of nuclear medicine, focuses on highlighting the production and application of radiopharmaceuticals. With this, the book also describes the chemical composition of these compounds, as well as some of the main clinical applications where radiopharmaceuticals may be used. Following an introduction to the field of radiopharmacy, three chapters in this book are dedicated towards in-depth descriptions of common radionuclides and radiopharmaceuticals used during diagnostic studies utilizing planar/Single Photon Emission Computed Tomography (SPECT) imaging, in addition to during Positron Emission Tomography (PET) imaging, and, finally, radiotherapy. These chapters are followed by those describing procedures relating to quality control and manufacturing (good manufacturing practices) also encompassing aspects such as environmental compliance. Furthermore, this volume illustrates how facilities handling these chemicals should be designed to comply with set regulations. Like many pharmaceuticals, the development of radiopharmaceuticals relies heavily on the use of mouse models. Thus, the translation of radiopharmaceuticals (i.e., the process undertaken to assure that the functionality and safety of a newly developed drug is maintained also in a human context), is covered in a later chapter. This is followed by a chapter emphasising the importance of safe waste disposal and how to assure that these procedures meet the requirements set for the disposal of hazardous waste. Several chapters have also been dedicated towards describing various medical procedures utilizing clinical nuclear medicine as a tool for diagnostics and therapeutics. As physicists may be involved in clinical trials, a chapter describing the procedures and regulations associated with these types of studies is included. This is followed by a chapter focusing on patient safety and another on an imaging modality not based on ionizing radiation – ultrasound. Finally, the last chapter of this book discusses future perspectives of the field of nuclear medicine. This text will be an invaluable resource for libraries, institutions, and clinical and academic medical physicists searching for a complete account of what defines nuclear medicine. The most comprehensive reference available providing a state-of-the-art overview of the field of nuclear medicine Edited by a leader in the field, with contributions from a team of experienced medical physicists, chemists, engineers, scientists, and clinical medical personnel Includes the latest practical research in the field, in addition to explaining fundamental theory and the field's history

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240001824
Category : Medical
Languages : en
Pages : 345

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Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240086080
Category : Business & Economics
Languages : en
Pages : 1354

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Book Description
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.

Author: Alice Longobardi Givan
Publisher: John Wiley & Sons
ISBN: 1118688392
Category : Science
Languages : en
Pages : 309

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Book Description
Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature.

Author:
Publisher: World Health Organization
ISBN: 9240037063
Category : Medical
Languages : en
Pages : 253

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Book Description
The third issue of Volume 35, includes Consultation Documents: - WHO Biowaiver Project – Preparation for Cycle V (2022): Prioritization Exercise of Active Pharmaceutical Ingredients on the WHO Model List of Essential Medicines for Solubility Determination and Biopharmaceutics Classification System-Based Classification- IAEA/WHO Guideline on Good Manufacturing Practices for Investigational Radiopharmaceutical Products - WHO Good Practices for Research and Development Facilities of Pharmaceutical Products - WHO Good Manufacturing Practices for Investigational Products - Medicinal Oxygen (oxygenium medicinalis) - Dolutegravir Dispersible Tablets (dolutegraviri compressi dispersibili) Issue 3 concludes with List No. 86 of Recommended International Nonproprietary Names (INN) for Pharmaceutical Substances.

Author: Adrian P. Gee
Publisher: Springer Nature
ISBN: 3030755371
Category : Science
Languages : en
Pages : 681

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Book Description
This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594

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Book Description
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 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

Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510

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Book Description
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy