Download or read book GMP in Practice written by Vesper and published by David Horwood International Pub Limited. This book was released on 2000-07 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sterile Filtration written by Maik W. Jornitz and published by CRC Press. This book was released on 2020-04-15 with total page 640 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration!
Download or read book Phase Appropriate GMP for Biological Processes written by Trevor Deeks and published by . This book was released on 2018-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biotechnology from Idea to Market written by Fred Mermelstein and published by . This book was released on 2019-08 with total page 1026 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles of Parenteral Solution Validation written by Igor Gorsky and published by Academic Press. This book was released on 2019-11-27 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. - Discusses international and domestic regulatory considerations in every section - Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs - Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more
Download or read book Understanding Pathological Demand Avoidance Syndrome in Children written by Margaret Duncan and published by Jessica Kingsley Publishers. This book was released on 2011-09-15 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: This straightforward guide offers a complete overview of Pathological Demand Avoidance Syndrome (PDA) and gives practical advice for overcoming the difficulties it poses in a wide range of contexts from diagnosis through to adulthood. Starting with an exploration into the background of PDA that answers many of the immediate questions triggered when a child is first diagnosed, the book goes on to look at the impact of the condition on different areas of the child's life and what can be done to help. The authors present useful information on early intervention options and workable strategies for managing PDA positively on a day-to-day basis. They also examine ways to minimize common difficulties that may be encountered at home and school, making life easier for the child, family and peers. The final chapters tackle new problems that can arise when the teenage years hit and how to assist a successful transition from adolescence to adulthood. Illustrative case examples are included throughout, and the book concludes with a list of valuable resources for further information and advice. Full of helpful guidance and support, this user-friendly introductory handbook is essential reading for anyone caring for, or working with, children with PDA.
Download or read book Water activity applications in the pharmaceutical industry written by Anthony J. Fontana and published by . This book was released on 2009 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Advanced Aseptic Processing Technology written by James Agalloco and published by CRC Press. This book was released on 2016-04-19 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies
Download or read book Cleaning Validation written by Destin A. LeBlanc and published by CRC Press. This book was released on 2022-12-23 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this volume will help in designing a more effective and efficient cleaning validation program. Features • Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. • The author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and riskbased approaches to cleaning validation. • Draws on the author’s vast experience in the field of cleaning validation and hazardous materials. • Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities. • A diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products.
Download or read book PDA by PDAers written by Sally Cat and published by Jessica Kingsley Publishers. This book was released on 2018-05-21 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: "To think of PDA as merely involving demand avoidance is to me akin to thinking of tigers as merely having stripes." This book is a unique window into adult Pathological Demand Avoidance (PDA), exploring the diversity of distinct PDA traits through the voices of over 70 people living with and affected by the condition. Sally Cat, an adult with PDA, has successfully captured the essence of a popular online support group in book form, making the valuable insights available to a wider audience, and creating a much-needed resource for individuals and professionals. Candid discussions cover issues ranging from overload and meltdowns, to work, relationships and parenting. This is a fascinating and sometimes very moving read.
Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-07-13 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Download or read book Respiratory Drug Delivery 1989 written by Peter R. Byron and published by CRC Press. This book was released on 2018-04-20 with total page 571 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is on subjects related to drug delivery to the lung. The text spans topics from aerosol deposition through pharmaceutical chemistry and formulation to the final clinical evaluation of pharmaceutical products. Utilizing a multi-disciplinary approach, the chapters consider toxicology from the point of view of drugs and pharmaceutical excipients used in aerosols.
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 2020-01-02 with total page 594 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 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 Quality by Design written by Siegfried Schmitt and published by . This book was released on 2011 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book PDA Technical Report No 28 Revised 2006 written by PDA and published by . This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Aseptic Processing written by Jack Lysfjord and published by Parenteral Drug Association. This book was released on 2009 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt:
