Principles Of Parenteral Solution Validation PDF Download
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| Author | : Igor Gorsky |
| Publisher | : Academic Press |
| Total Pages | : 300 |
| Release | : 2019-11-27 |
| Genre | : Medical |
| ISBN | : 012809446X |
Download Principles of Parenteral Solution Validation Book in PDF, ePub and Kindle
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
| Author | : David N. Muchemu |
| Publisher | : Createspace Independent Publishing Platform |
| Total Pages | : 0 |
| Release | : 2010-04-29 |
| Genre | : |
| ISBN | : 9781452843186 |
Download Principles of Process Validation Book in PDF, ePub and Kindle
This book discusses the verious principles governing process validation.It introduces concepts and breaks the concepts down to a level any reader can understand.
| Author | : Hazel Aranha |
| Publisher | : CRC Press |
| Total Pages | : 372 |
| Release | : 2023-03-17 |
| Genre | : Science |
| ISBN | : 1000864200 |
Download Handbook of Cell and Gene Therapy Book in PDF, ePub and Kindle
This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish, as well as delivery options. Planning steps for compliance with current good manufacturing practice (cGMP) to readiness for chemistry, manufacturing and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing Discusses siRNA, mRNA, and plasmid manufacturing Describes the importance of supplier-sponsor synergies on the path to commercialization Written for a diverse audience with a large number of individuals in the core technologies and supportive practices It is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions.
| Author | : Parag Kolhe |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 590 |
| Release | : 2013-10-12 |
| Genre | : Medical |
| ISBN | : 1461479789 |
Download Sterile Product Development Book in PDF, ePub and Kindle
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
| Author | : Ajay Babu Pazhayattil |
| Publisher | : Springer |
| Total Pages | : 92 |
| Release | : 2018-11-16 |
| Genre | : Medical |
| ISBN | : 3030024725 |
Download Solid Oral Dose Process Validation Book in PDF, ePub and Kindle
Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
| Author | : |
| Publisher | : Amer Soc Health-System Pharmacists |
| Total Pages | : 196 |
| Release | : 1995 |
| Genre | : Medical |
| ISBN | : |
Download Principles of Sterile Product Preparation Book in PDF, ePub and Kindle
| Author | : Michael J. Akers |
| Publisher | : CRC Press |
| Total Pages | : 517 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420020560 |
Download Sterile Drug Products Book in PDF, ePub and Kindle
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
| Author | : |
| Publisher | : |
| Total Pages | : 32 |
| Release | : 1987 |
| Genre | : Medical instruments and apparatus industry |
| ISBN | : |
Download Guideline on General Principles of Process Validation Book in PDF, ePub and Kindle
| Author | : Chung Chow Chan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 320 |
| Release | : 2004-04-23 |
| Genre | : Science |
| ISBN | : 047146371X |
Download Analytical Method Validation and Instrument Performance Verification Book in PDF, ePub and Kindle
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
| Author | : Alice Longobardi Givan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 309 |
| Release | : 2013-04-10 |
| Genre | : Science |
| ISBN | : 1118688392 |
Download Flow Cytometry Book in PDF, ePub and Kindle
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.
