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

Guideline on General Principles of Process Validation

Guideline on General Principles of Process Validation
Author: Anonim
Publsiher: Unknown
Total Pages: 25
Release: 1987
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015029699587
Language: EN, FR, DE, ES & NL

Guideline on General Principles of Process Validation Book Review:

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 1420019791
ISBN 13: 9781420019797
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

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: 2021-10-18
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

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
Author: Sandeep Nema,John D. Ludwig
Publsiher: CRC Press
Total Pages: 1125
Release: 2019-08-08
ISBN 10: 042957472X
ISBN 13: 9780429574726
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

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.

Principles of Fermentation Technology

Principles of Fermentation Technology
Author: Peter F Stanbury,Allan Whitaker,Stephen J Hall
Publsiher: Butterworth-Heinemann
Total Pages: 824
Release: 2016-08-31
ISBN 10: 0444634088
ISBN 13: 9780444634085
Language: EN, FR, DE, ES & NL

Principles of Fermentation Technology Book Review:

The successful structure of the previous edition of Principles of Fermentation Technology has been retained in this third edition, which covers the key component parts of a fermentation process including growth kinetics, strain isolation and improvement, inocula development, fermentation media, fermenter design and operation, product recovery, and the environmental impact of processes. This accurate and accessible third edition recognizes the increased importance of animal cell culture, the impact of the post-genomics era on applied science and the huge contribution that heterologous protein production now makes to the success of the pharmaceutical industry. This title is ideally suited for both newcomers to the industry and established workers as it provides essential and fundamental information on fermentation in a methodical, logical fashion. Stanbury, Whitaker and Hall have integrated the biological and engineering aspects of fermentation to make the content accessible to members of both disciplines with a focus on the practical application of theory. This text collates all the fermentation fundamentals into one concise reference, making it a valuable resource for fermentation scientists, as well as those studying in the field. Retains its successful structure and covers all components of the fermentation process Integrates the biological and engineering aspects of fermentation to discuss the most recent developments and advancements in the field Written in a style accessible to readers from either a biological or engineering background with each chapter supported by an extensive bibliography

Solid Oral Dose Process Validation Volume Two

Solid Oral Dose Process Validation  Volume Two
Author: Ajay Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Marzena Ingram,Jordan Collins
Publsiher: Springer Nature
Total Pages: 108
Release: 2019-08-30
ISBN 10: 3030274845
ISBN 13: 9783030274849
Language: EN, FR, DE, ES & NL

Solid Oral Dose Process Validation Volume Two Book Review:

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Disinfection and Decontamination

Disinfection and Decontamination
Author: Jeanne Moldenhauer
Publsiher: CRC Press
Total Pages: 254
Release: 2018-11-20
ISBN 10: 1351217003
ISBN 13: 9781351217002
Language: EN, FR, DE, ES & NL

Disinfection and Decontamination Book Review:

This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for decontamination across industries. Finally, this book provides a single resource on how one can address contamination issues for a variety of manufacturing processes and industries.

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:

Principles and Practice of Multi Agent Systems

Principles and Practice of Multi Agent Systems
Author: Nirmit Desai,Alan Liu,Michael Winikoff
Publsiher: Springer Science & Business Media
Total Pages: 650
Release: 2012-01-09
ISBN 10: 3642259197
ISBN 13: 9783642259197
Language: EN, FR, DE, ES & NL

Principles and Practice of Multi Agent Systems Book Review:

This book constitutes the thoroughly refereed post-conference proceedings of the 13th International Conference on Principles and Practice of Multi-Agent Systems, PRIMA 2010, held in Kolkata, India, in November 2010. The 18 full papers presented together with 15 early innovation papers were carefully reviewed and selected from over 63 submissions. They focus on practical aspects of multiagent systems and cover topics such as agent communication, agent cooperation and negotiation, agent reasoning, agent-based simulation, mobile and semantic agents, agent technologies for service computing, agent-based system development, ServAgents workshop, IAHC workshop, and PRACSYS workshop.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
Author: Kenneth E. Avis
Publsiher: Routledge
Total Pages: 592
Release: 2018-05-04
ISBN 10: 1351425188
ISBN 13: 9781351425186
Language: EN, FR, DE, ES & NL

Pharmaceutical Dosage Forms Book Review:

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

Process Validation in Manufacturing of Biopharmaceuticals

Process Validation in Manufacturing of Biopharmaceuticals
Author: Anurag S. Rathore,Gail Sofer
Publsiher: CRC Press
Total Pages: 532
Release: 2012-05-09
ISBN 10: 1439850941
ISBN 13: 9781439850947
Language: EN, FR, DE, ES & NL

Process Validation in Manufacturing of Biopharmaceuticals Book Review:

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms
Author: Sandeep Nema,John D. Ludwig
Publsiher: CRC Press
Total Pages: 500
Release: 2010-08-26
ISBN 10: 1482281783
ISBN 13: 9781482281781
Language: EN, FR, DE, ES & NL

Pharmaceutical Dosage Forms Book Review:

Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products

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.

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:

Solid Oral Dose Process Validation

Solid Oral Dose Process Validation
Author: Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Jordan Collins
Publsiher: Springer
Total Pages: 92
Release: 2018-11-16
ISBN 10: 3030024725
ISBN 13: 9783030024727
Language: EN, FR, DE, ES & NL

Solid Oral Dose Process Validation Book Review:

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.

Cumulated Index Medicus

Cumulated Index Medicus
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 1991
ISBN 10: 1928374650XXX
ISBN 13: UIUC:30112023522896
Language: EN, FR, DE, ES & NL

Cumulated Index Medicus Book Review:

Separations Technology

Separations Technology
Author: Wayne P. Olson
Publsiher: CRC Press
Total Pages: 576
Release: 2020-02-03
ISBN 10: 1000725049
ISBN 13: 9781000725049
Language: EN, FR, DE, ES & NL

Separations Technology Book Review:

Authored by a team of respected scientists and technologists, this book covers many pharmaceutical and biotechnology separations methods currently in use. Practical applications and descriptions are offered for air elutriation, microporous filtration, ultrafiltration, phase partitioning, crystallization, and chromatographic technologies such as adsorption, affinity, chelate, ion-exchange, size-exclusion, template, hydrophobic interaction, biotransformations, and chiral separations. Containing hundreds of references and a complete index, this book is designed for research and development scientists, process optimization engineers, and quality control laboratory scientists as well as quality assurance professionals and others needing to understand current separation techniques.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.