Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Author: Igor Gorsky,Harold S. Baseman
Publsiher: Academic Press
Total Pages: 208
Release: 2019-04-15
ISBN 10: 0128094125
ISBN 13: 9780128094129
Language: EN, FR, DE, ES & NL

Principles of Parenteral Solution Validation Book Review:

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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
Author: Igor Gorsky,Harold S. Baseman
Publsiher: Academic Press
Total Pages: 298
Release: 2019-11-27
ISBN 10: 012809446X
ISBN 13: 9780128094464
Language: EN, FR, DE, ES & NL

Principles of Parenteral Solution Validation Book Review:

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

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation
Author: E. Clyde Buchanan
Publsiher: Amer Soc of Health System
Total Pages: 182
Release: 1995
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015037342428
Language: EN, FR, DE, ES & NL

Principles of Sterile Product Preparation Book Review:

Pharmaceutical Process Validation Second Edition

Pharmaceutical Process Validation  Second Edition
Author: Ira R. Berry,Robert A. Nash
Publsiher: CRC Press
Total Pages: 602
Release: 1993-01-29
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015029467159
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Validation Second Edition Book Review:

Updated to reflect current good manufacturing practice (CGMP) regulations, this text discusses current concepts in validation. New topics covered include: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Pharmaceutical Process Validation

Pharmaceutical Process Validation
Author: Bernard T. Loftus,Robert A. Nash
Publsiher: Marcel Dekker Incorporated
Total Pages: 286
Release: 1984
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015006032687
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Validation Book Review:

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Handbook of Validation in Pharmaceutical Processes  Fourth Edition
Author: James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publsiher: CRC Press
Total Pages: 1061
Release: 2021-10-28
ISBN 10: 1000436012
ISBN 13: 9781000436013
Language: EN, FR, DE, ES & NL

Handbook of Validation in Pharmaceutical Processes Fourth Edition Book Review:

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

Disinfection Sterilization and Preservation

Disinfection  Sterilization  and Preservation
Author: Seymour Stanton Block
Publsiher: Williams & Wilkins
Total Pages: 1162
Release: 1991
ISBN 10: 1928374650XXX
ISBN 13: MINN:31951P00519178O
Language: EN, FR, DE, ES & NL

Disinfection Sterilization and Preservation Book Review:

Now in its thoroughly revised, updated Fifth Edition, this volume is a comprehensive, practical reference on contemporary methods of disinfection, sterilization, and preservation and their medical, surgical, and public health applications. More than a third of this edition's chapters cover subjects never addressed in previous editions. New topics covered include recently identified pathogens, microbial biofilms, use of antibiotics as antiseptics, synergism between chemical microbicides, pulsed-light sterilization of pharmaceuticals, and new methods for medical waste management. Close attention is given to infection control problems posed by endoscopes, implants, prostheses, and organ transplantation and to prevention of opportunistic infections in immunocompromised patients. A Brandon-Hill recommended title.

Validation Standard Operating Procedures

Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publsiher: CRC Press
Total Pages: 1144
Release: 2006-05-30
ISBN 10: 1420009419
ISBN 13: 9781420009415
Language: EN, FR, DE, ES & NL

Validation Standard Operating Procedures Book Review:

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Best Practices for Hospital Health system Pharmacy

Best Practices for Hospital   Health system Pharmacy
Author: American Society of Health-System Pharmacists
Publsiher: Unknown
Total Pages: 135
Release: 2007
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015045509646
Language: EN, FR, DE, ES & NL

Best Practices for Hospital Health system Pharmacy Book Review:

Best Practices for Health system Pharmacy

Best Practices for Health system Pharmacy
Author: American Society of Health-System Pharmacists
Publsiher: Unknown
Total Pages: 660
Release: 2003
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015056550588
Language: EN, FR, DE, ES & NL

Best Practices for Health system Pharmacy Book Review:

Modern Pharmaceutics Volume 1

Modern Pharmaceutics Volume 1
Author: Alexander T. Florence,Juergen Siepmann
Publsiher: CRC Press
Total Pages: 656
Release: 2009-05-28
ISBN 10: 1420065653
ISBN 13: 9781420065657
Language: EN, FR, DE, ES & NL

Modern Pharmaceutics Volume 1 Book Review:

With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics. Key topics in Volume 1 include: • principles of drug absorption, chemical kinetics, and drug stability • pharmacokinetics • the effect of route of administration and distribution on drug action • in vivo imaging of dose forms: gamma scintigraphy, PET imaging NMR, MRI, etc. • powder technology • excipient design and characterization • preformulation • optimization techniques in pharmaceutical formulation and processing • disperse and surfactant systems • the solid state, tablet dosage forms, coating processes, and hard and soft shell capsules • parenteral products

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
Author: Sandeep Nema,John D. Ludwig
Publsiher: CRC Press
Total Pages: 1125
Release: 2019-07-19
ISBN 10: 0429576838
ISBN 13: 9780429576836
Language: EN, FR, DE, ES & NL

Parenteral Medications Fourth Edition Book Review:

Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements

Validation of Aseptic Pharmaceutical Processes

Validation of Aseptic Pharmaceutical Processes
Author: Frederick J. Carleton,James P. Agalloco
Publsiher: Marcel Dekker
Total Pages: 728
Release: 1986
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015010137415
Language: EN, FR, DE, ES & NL

Validation of Aseptic Pharmaceutical Processes Book Review:

Drug Stability

Drug Stability
Author: Jens Thurø Carstensen
Publsiher: Marcel Dekker
Total Pages: 601
Release: 1995
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015034859911
Language: EN, FR, DE, ES & NL

Drug Stability Book Review:

Combining basic theory, current industrial practice, and useful regulatory aspects in an original overview of pharmaceutical stability, this thoroughly rewritten and enlarged reference/text examines data analysis of the packaged drug's stability, experimental methods for achieving stable marketed products, and the stability principles of drugs in dissolved, dispersed, and solid states.

21 CFR Part 11

21 CFR Part 11
Author: Orlando López
Publsiher: CRC Press
Total Pages: 243
Release: 2004-01-15
ISBN 10: 1135488754
ISBN 13: 9781135488758
Language: EN, FR, DE, ES & NL

21 CFR Part 11 Book Review:

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places

Bioseparation and Bioprocessing Volume I Biochromatography Membrane Separations Modeling Validation Volume II Processing Quality and Characterisation Economics Safety and Hygiene

Bioseparation and Bioprocessing  Volume I  Biochromatography   Membrane Separations   Modeling   Validation  Volume II  Processing   Quality and Characterisation   Economics  Safety and Hygiene
Author: G. Subramanian
Publsiher: Wiley-VCH
Total Pages: 1052
Release: 1998
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015043114753
Language: EN, FR, DE, ES & NL

Bioseparation and Bioprocessing Volume I Biochromatography Membrane Separations Modeling Validation Volume II Processing Quality and Characterisation Economics Safety and Hygiene Book Review:

Rapid developments in biotechnology create a demand for practical, up-to-date reviews written by and for experts in industry. This compact handbook provides all relevant up-to-date information on important bioseparation and bioprocessing techniques that are actively applied in the biotechnology industries. The handbook presents an applications-orientated overview on - case studies and general strategies for quality control and characterization - detailed guidelines on developing economic and technically feasible bioseparation schemes - strategies and methods for intracellular bioproduct release - chromatographic and membrane downstream processes used in biotechnology - applications of modern non-invasive methods such as neural networks for on-line estimation and control of fermentation variables on an industrial scale - a practical, commercially-relevant guide to biosafety and many more aspects which are indispensible for present and future industrial success.

Sterilization Technology

Sterilization Technology
Author: Robert F. Morrissey,G. Briggs Phillips
Publsiher: Springer
Total Pages: 518
Release: 1993-02-28
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015057696620
Language: EN, FR, DE, ES & NL

Sterilization Technology Book Review:

Includes as many case studies as the contributors could identify, with the goal of answering questions that arise as a result of conducting day-to-day sterilization activities. Discussion of the theory of microbial inactivation and the philosophy of sterilization validation is followed by practical information on methods of interest to a broad audience. Chapters on special considerations for ethylene oxide, packaging of sterile products, contract sterilization, and regulations complete the coverage. Annotation copyright by Book News, Inc., Portland, OR

Advanced Aseptic Processing Technology

Advanced Aseptic Processing Technology
Author: James Agalloco,James Akers
Publsiher: CRC Press
Total Pages: 496
Release: 2016-04-19
ISBN 10: 1439825440
ISBN 13: 9781439825440
Language: EN, FR, DE, ES & NL

Advanced Aseptic Processing Technology Book Review:

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 for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: The use of isolator and barrier concepts for aseptic processing and assembly. The application of robotics as an alternative to gowned personnel. The increasing reliance on automation to minimize or eliminate operator intervention. The design, operational, monitoring and compliance changes necessary for success with advanced aseptic processing. Advanced Aseptic Processing Technology is an essential reference for anyone working with sterile products, and is recommended for individuals in manufacturing,, compliance, regulatory affairs, microbiology, environmental monitoring, sterility testing, sterilization, validation, engineering, development, facility and equipment design, component and equipment suppliers, automation, and robotics.

Sterile Product Development

Sterile Product Development
Author: Parag Kolhe,Mrinal Shah,Nitin Rathore
Publsiher: Springer Science & Business Media
Total Pages: 585
Release: 2013-10-12
ISBN 10: 1461479789
ISBN 13: 9781461479789
Language: EN, FR, DE, ES & NL

Sterile Product Development Book Review:

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.

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification
Author: Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2004-04-23
ISBN 10: 047146371X
ISBN 13: 9780471463719
Language: EN, FR, DE, ES & NL

Analytical Method Validation and Instrument Performance Verification Book Review:

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.