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Principles Of Parenteral Solution Validation

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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-04-15
ISBN : 0128094125
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-11-27
ISBN : 012809446X
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Anonim
Publisher : Unknown
Release : 1987
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Guideline on General Principles of Process Validation book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition Book
Author : Sandeep Nema,John D. Ludwig
Publisher : CRC Press
Release : 2019-07-19
ISBN : 0429576838
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Validation in Pharmaceutical Processes Fourth Edition

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book
Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Release : 2021-10-18
ISBN : 1000436012
Language : En, Es, Fr & De

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Book Description :

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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes Book
Author : James P. Agalloco,Frederick J. Carleton
Publisher : CRC Press
Release : 2007-09-25
ISBN : 9781420019797
Language : En, Es, Fr & De

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Book Description :

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

Pharmaceutical Process Validation Second Edition

Pharmaceutical Process Validation  Second Edition Book
Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Release : 1993-01-29
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 and Practice of Multi Agent Systems

Principles and Practice of Multi Agent Systems Book
Author : Nirmit Desai,Alan Liu,Michael Winikoff
Publisher : Springer
Release : 2011-12-17
ISBN : 3642259200
Language : En, Es, Fr & De

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Book Description :

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 Process Validation

Pharmaceutical Process Validation Book
Author : Bernard T. Loftus,Robert A. Nash
Publisher : Marcel Dekker Incorporated
Release : 1984
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Pharmaceutical Process Validation book written by Bernard T. Loftus,Robert A. Nash, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Pharmaceutical Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Kenneth E. Avis
Publisher : Routledge
Release : 2018-05-04
ISBN : 1351425188
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Anurag S. Rathore,Gail Sofer
Publisher : CRC Press
Release : 2012-05-09
ISBN : 1439850941
Language : En, Es, Fr & De

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Book Description :

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

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation Book
Author : E. Clyde Buchanan
Publisher : Amer Soc of Health System
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Principles of Sterile Product Preparation book written by E. Clyde Buchanan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis Book
Author : Satinder Ahuja,Stephen Scypinski
Publisher : Elsevier
Release : 2001-08-02
ISBN : 9780080488929
Language : En, Es, Fr & De

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Book Description :

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Separations Technology

Separations Technology Book
Author : Wayne P. Olson
Publisher : CRC Press
Release : 2020-02-03
ISBN : 1000725049
Language : En, Es, Fr & De

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Book Description :

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 Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470259809
Language : En, Es, Fr & De

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Book Description :

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.

Cleanroom Microbiology for the Non Microbiologist

Cleanroom Microbiology for the Non Microbiologist Book
Author : David M. Carlberg
Publisher : CRC Press
Release : 1995-04-30
ISBN : 9780935184730
Language : En, Es, Fr & De

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Book Description :

Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The book introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods. This book is especially relevant for supervisors and managers who need a sound understanding of contamination control and is particularly effective for use in training. It also is an excellent resource for validation engineers, quality assurance and non-microbiologist quality-control staff, maintenance personnel, and process development staff.

Validation Compliance Annual

Validation Compliance Annual Book
Author : International Validation Forum
Publisher : CRC Press
Release : 1995-02-17
ISBN : 9780824794590
Language : En, Es, Fr & De

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Book Description :

"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Validation of Aseptic Pharmaceutical Processes

Validation of Aseptic Pharmaceutical Processes Book
Author : Frederick J. Carleton,James P. Agalloco
Publisher : Marcel Dekker
Release : 1986
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Validation of Aseptic Pharmaceutical Processes book written by Frederick J. Carleton,James P. Agalloco, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Control of Particulate Matter Contamination in Healthcare Manufacturing

Control of Particulate Matter Contamination in Healthcare Manufacturing Book
Author : Thomas A. Barber
Publisher : CRC Press
Release : 1999-10-31
ISBN : 9781574910728
Language : En, Es, Fr & De

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Book Description :

This book offers practical applications addressing the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality considerations. Written by an industry expert, this material offers a clear and concise understanding of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. Complete with a full-color insert of micrographs illustrating commonly encountered particulate matter and over eighty figures, tables, and charts. Features

Sterile Drug Products

Sterile Drug Products Book
Author : Michael J. Akers
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420020560
Language : En, Es, Fr & De

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Book Description :

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.