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:
ISBN 13: UOM:39015029699587
Language: EN, FR, DE, ES & NL

Guideline on General Principles of Process Validation Book Review:

Process Validation in Manufacturing of Biopharmaceuticals Third Edition

Process Validation in Manufacturing of Biopharmaceuticals  Third Edition
Author: Anurag S. Rathore,Gail Sofer
Publsiher: CRC Press
Total Pages: 531
Release: 2012-05-09
ISBN 10: 1439850933
ISBN 13: 9781439850930
Language: EN, FR, DE, ES & NL

Process Validation in Manufacturing of Biopharmaceuticals Third Edition 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 final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Principles of Process Validation

Principles of Process Validation
Author: David N. Muchemu
Publsiher: CreateSpace
Total Pages: 118
Release: 2010-04-29
ISBN 10: 9781452843186
ISBN 13: 145284318X
Language: EN, FR, DE, ES & NL

Principles of Process Validation Book Review:

This book discusses the verious principles governing process validation.It introduces concepts and breaks the concepts down to a level any reader can understand.

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.

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.

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.

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: 9781420019797
ISBN 13: 1420019791
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

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 218
Release: 2016-06-07
ISBN 10: 0128096535
ISBN 13: 9780128096536
Language: EN, FR, DE, ES & NL

How to Validate a Pharmaceutical Process Book Review:

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Pharmaceutical Process Validation

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

Pharmaceutical Process Validation Book Review:

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

Pharmaceutical Process Scale Up Third Edition

Pharmaceutical Process Scale Up  Third Edition
Author: Michael Levin
Publsiher: CRC Press
Total Pages: 530
Release: 2011-02-02
ISBN 10: 9781616310011
ISBN 13: 1616310014
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Scale Up Third Edition Book Review:

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Remington

Remington
Author: Adeboye Adejare
Publsiher: Academic Press
Total Pages: 1030
Release: 2020-11-03
ISBN 10: 0128223898
ISBN 13: 9780128223895
Language: EN, FR, DE, ES & NL

Remington Book Review:

Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology
Author: Dilip Parikh
Publsiher: Academic Press
Total Pages: 210
Release: 2017-04-04
ISBN 10: 0128047283
ISBN 13: 9780128047286
Language: EN, FR, DE, ES & NL

How to Optimize Fluid Bed Processing Technology Book Review:

How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation. Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques Offers troubleshooting tips and practical advice for scientists working with this technique

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

Sterile Drug Products

Sterile Drug Products
Author: Michael J. Akers
Publsiher: CRC Press
Total Pages: 516
Release: 2016-04-19
ISBN 10: 1420020560
ISBN 13: 9781420020564
Language: EN, FR, DE, ES & NL

Sterile Drug Products Book Review:

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.

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: 9781420019797
ISBN 13: 1420019791
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

Validation Standard Operating Procedures

Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publsiher: CRC Press
Total Pages: 1144
Release: 2006-05-30
ISBN 10: 9781420009415
ISBN 13: 1420009419
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

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.

Fast Facts for Nurses about Home Infusion Therapy

Fast Facts for Nurses about Home Infusion Therapy
Author: Lisa A. Gorski, MS, RN, HHCNS-BC, CRNI, FAAN
Publsiher: Springer Publishing Company
Total Pages: 254
Release: 2017-04-26
ISBN 10: 0826160069
ISBN 13: 9780826160065
Language: EN, FR, DE, ES & NL

Fast Facts for Nurses about Home Infusion Therapy Book Review:

Features concise information "at a glance" along with more in-depth considerations Providing key information at a glance, this timely resource for the home care nurse, offers clear, current practice guidelines for safely delivering IV therapy within the home. Written by one of the foremost experts in the field, the guide delivers not only evidence-based information in an easy-to-access, bulleted format, but also includes more extensive descriptions, discussions, and rationale for in-depth consultation. It maintains a cogent focus on infection and complication prevention throughout, and presents directives for achieving positive patient outcomes. It also focuses on patient education—an essential component of safe home infusion therapy--and includes case studies and Q & A sections to reinforce content. The guide addresses the foundations of home infusion therapy, including infusion access devices and infusion delivery methods. Effective and safe management of dehydration, antimicrobial infusions, and parenteral nutrition are addressed along with chemotherapy, pain management, cardiac-related infusion therapy, immunoglobulin infusion, and other home infusion therapies. Home care nurses who provide direct care, home care managers and educators, and nurses who provide home care discharge planning will find this Fast Facts guide to be an invaluable learning tool. Key Features: Focuses on patient selection, education, and monitoring Delivers evidence-based recommendations Presents quick access bullet points along with more in-depth information Discusses pediatric and geriatric implications Includes case studies and critical thinking questions