Principles of Parenteral Solution Validation Books

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Principles of Parenteral Solution Validation


Principles of Parenteral Solution Validation
  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Release : 2019-04-15
  • ISBN : 9780128094129
  • Language : En, Es, Fr & De
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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 :
  • Publisher :
  • Release : 1987
  • ISBN : UOM:39015029699587
  • Language : En, Es, Fr & De
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Parenteral Medications Fourth Edition


Parenteral Medications  Fourth Edition
  • Author : Sandeep Nema
  • Publisher : CRC Press
  • Release : 2019-07-19
  • ISBN : 9780429576836
  • Language : En, Es, Fr & De
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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 Validation Second Edition


Pharmaceutical Process Validation  Second Edition
  • Author : Ira R. Berry
  • Publisher : CRC Press
  • Release : 1993-01-29
  • ISBN : UOM:39015029467159
  • Language : En, Es, Fr & De
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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
  • Publisher : Amer Soc of Health System
  • Release : 1995
  • ISBN : UOM:39015037342428
  • Language : En, Es, Fr & De
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