Principles of Parenteral Solution Validation

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Author :
Publisher : Academic Press
ISBN 13 : 0128094125
Total Pages : 298 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Principles of Parenteral Solution Validation by : Igor Gorsky

Download or read book Principles of Parenteral Solution Validation written by Igor Gorsky and published by Academic Press. This book was released on 2019-04-15 with total page 298 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

Principles of Parenteral Solution Validation

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Author :
Publisher : Academic Press
ISBN 13 : 012809446X
Total Pages : 300 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Principles of Parenteral Solution Validation by : Igor Gorsky

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

Principles of Process Validation

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Author :
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781452843186
Total Pages : 0 pages
Book Rating : 4.8/5 (431 download)

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Book Synopsis Principles of Process Validation by : David N. Muchemu

Download or read book Principles of Process Validation written by David N. Muchemu and published by Createspace Independent Publishing Platform. This book was released on 2010-04-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the verious principles governing process validation.It introduces concepts and breaks the concepts down to a level any reader can understand.

Handbook of Cell and Gene Therapy

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Author :
Publisher : CRC Press
ISBN 13 : 1000864200
Total Pages : 372 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Handbook of Cell and Gene Therapy by : Hazel Aranha

Download or read book Handbook of Cell and Gene Therapy written by Hazel Aranha and published by CRC Press. This book was released on 2023-03-17 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sterile Product Development

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 585 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Sterile Product Development by : Parag Kolhe

Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 585 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sterile Drug Products

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Author :
Publisher : CRC Press
ISBN 13 : 1420020560
Total Pages : 516 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Sterile Drug Products by : Michael J. Akers

Download or read book Sterile Drug Products written by Michael J. Akers and published by CRC Press. This book was released on 2016-04-19 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Solid Oral Dose Process Validation

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Author :
Publisher : Springer
ISBN 13 : 3030024725
Total Pages : 92 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Solid Oral Dose Process Validation by : Ajay Babu Pazhayattil

Download or read book Solid Oral Dose Process Validation written by Ajay Babu Pazhayattil and published by Springer. This book was released on 2018-11-16 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Principles of Sterile Product Preparation

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Author :
Publisher : Amer Soc Health-System Pharmacists
ISBN 13 :
Total Pages : 196 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Principles of Sterile Product Preparation by :

Download or read book Principles of Sterile Product Preparation written by and published by Amer Soc Health-System Pharmacists. This book was released on 1995 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Analytical Method Validation and Instrument Performance Verification

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 047146371X
Total Pages : 320 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Analytical Method Validation and Instrument Performance Verification by : Chung Chow Chan

Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Flow Cytometry

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Publisher : John Wiley & Sons
ISBN 13 : 1118688392
Total Pages : 309 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Flow Cytometry by : Alice Longobardi Givan

Download or read book Flow Cytometry written by Alice Longobardi Givan and published by John Wiley & Sons. This book was released on 2013-04-10 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Validation Standard Operating Procedures

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Author :
Publisher : CRC Press
ISBN 13 : 1420009419
Total Pages : 1144 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Validation Standard Operating Procedures by : Syed Imtiaz Haider

Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2006-05-30 with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Guideline on General Principles of Process Validation

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Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline on General Principles of Process Validation by :

Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Basics of FMEA

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Author :
Publisher : CRC Press
ISBN 13 : 1439809615
Total Pages : 90 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis The Basics of FMEA by : Raymond J. Mikulak

Download or read book The Basics of FMEA written by Raymond J. Mikulak and published by CRC Press. This book was released on 2017-08-09 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Demonstrates How To Perform FMEAs Step-by-StepOriginally designed to address safety concerns, Failure Mode and Effect Analysis (FMEA) is now used throughout the industry to prevent a wide range of process and product problems. Useful in both product design and manufacturing, FMEA can identify improvements early when product and process changes are

Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens

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Author :
Publisher : United Nations Publications
ISBN 13 : 9789211482430
Total Pages : 67 pages
Book Rating : 4.4/5 (824 download)

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Book Synopsis Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens by : United Nations

Download or read book Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens written by United Nations and published by United Nations Publications. This book was released on 2009 with total page 67 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation of analytical methods and the calibration of equipment are important aspects of quality assurance in the laboratory. This manual deals with both of these within the context of testing of illicit drugs in seized materials and biological specimens. It provides an introduction and practical guidance to national authorities and analysts in the implementation of method validation and verification, and also in the calibration/performance verification of laboratory instrumentation and equipment within their existing internal quality assurance programmes. The procedures described represent a synthesis of the experience of scientists from several reputable laboratories around the world.

Quality Assurance of Aseptic Preparation Services

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Publisher :
ISBN 13 : 9780857113078
Total Pages : 0 pages
Book Rating : 4.1/5 (13 download)

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Book Synopsis Quality Assurance of Aseptic Preparation Services by : Alison M. Beaney

Download or read book Quality Assurance of Aseptic Preparation Services written by Alison M. Beaney and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.

Handbook of Stability Testing in Pharmaceutical Development

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

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Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Approved Prescription Drug Products with Therapeutic Equivalence Evaluations

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Author :
Publisher :
ISBN 13 :
Total Pages : 336 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Approved Prescription Drug Products with Therapeutic Equivalence Evaluations by :

Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1984 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.