Principles of Parenteral Solution Validation

Written By Igor Gorsky
Principles of Parenteral Solution Validation
  • Publsiher : Academic Press
  • Release : 15 April 2019
  • ISBN : 0128094125
  • Pages : 208 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Principles of Parenteral Solution Validation written by Igor Gorsky which was release on 15 April 2019, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. 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

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release Date : 2019-04-15
  • Total pages : 208
  • ISBN : 0128094125
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Summary : 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 ...

Guideline on General Principles of Process Validation

Guideline on General Principles of Process Validation
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1987
  • Total pages : 25
  • ISBN : 0128094125
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Summary : Download or read online Guideline on General Principles of Process Validation written by , published by which was released on 1987. Get Guideline on General Principles of Process Validation Books now! Available in PDF, ePub and Kindle....

Parenteral Medications Fourth Edition

Parenteral Medications  Fourth Edition
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release Date : 2019-07-19
  • Total pages : 1125
  • ISBN : 0128094125
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Summary : 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 ...

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Total pages : 760
  • ISBN : 0128094125
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Summary : 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

Pharmaceutical Process Validation
  • Author : Bernard T. Loftus,Robert A. Nash
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1984
  • Total pages : 286
  • ISBN : 0128094125
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Summary : Download or read online Pharmaceutical Process Validation written by Bernard T. Loftus,Robert A. Nash, published by Marcel Dekker Incorporated which was released on 1984. Get Pharmaceutical Process Validation Books now! Available in PDF, ePub and Kindle....

Principles of Sterile Product Preparation

Principles of Sterile Product Preparation
  • Author : E. Clyde Buchanan
  • Publisher : Amer Soc of Health System
  • Release Date : 1995
  • Total pages : 182
  • ISBN : 0128094125
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Summary : Download or read online Principles of Sterile Product Preparation written by E. Clyde Buchanan, published by Amer Soc of Health System which was released on 1995. Get Principles of Sterile Product Preparation Books now! Available in PDF, ePub and Kindle....

Pharmaceutical Process Validation Second Edition

Pharmaceutical Process Validation  Second Edition
  • Author : Ira R. Berry,Robert A. Nash
  • Publisher : CRC Press
  • Release Date : 1993-01-29
  • Total pages : 602
  • ISBN : 0128094125
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Summary : 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 Practice of Pain Medicine Second Edition

Principles   Practice of Pain Medicine  Second Edition
  • Author : Carol A. Warfield,Zahid H. Bajwa
  • Publisher : McGraw-Hill Education / Medical
  • Release Date : 2004-04-05
  • Total pages : 938
  • ISBN : 0128094125
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Summary : The leading textbook on pain management! A Doody's Core Title! 4 STAR DOODY'S REVIEW! "This is an extraordinarily well-written and comprehensive book. It expands considerably on the first edition, and with its multifaceted and multidisciplinary perspective, it should be an invaluable addition to the library of any practitioner of pain medicine."...

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
  • Publisher : Springer Nature
  • Release Date : 2019-08-30
  • Total pages : 108
  • ISBN : 0128094125
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Summary : 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 Oral Dose Process Validation

Solid Oral Dose Process Validation
  • Author : Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Jordan Collins
  • Publisher : Springer
  • Release Date : 2018-11-16
  • Total pages : 92
  • ISBN : 0128094125
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Summary : 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 ...

Particle Size Distribution II

Particle Size Distribution II
  • Author : American Chemical Society. Meeting
  • Publisher : Amer Chemical Society
  • Release Date : 1991
  • Total pages : 407
  • ISBN : 0128094125
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Summary : Complementing ACS Symposium Series No. 332, Particle Size Distribution, this volume is a compendium of the current work in the field and features the latest technology now in use for particle size distribution assessment. Among the new techniques discussed are capillary hydrodynamic fractionation, field flow fractionation, disc centrifuge photosedimentometry, on-line measurements, ...

Best Practices for Health System Pharmacy 2003 2004

Best Practices for Health System Pharmacy 2003 2004
  • Author : American Society of Health-System Pharmacists
  • Publisher : Amer Soc of Health System
  • Release Date : 2003
  • Total pages : 638
  • ISBN : 0128094125
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Summary : More than half a century ago, the American Society of Health-System Pharmacists developed its earliest proposed practice standard -- the Proposed Minimum Standards for Pharmacies in Hospitals. Today, ASHP continues to foster concrete improvements in pharmacy practice and in the therapeutic use of drugs with Best Practices for Health-System Pharmacy: ...

Topley Wilson s Principles of Bacteriology Virology and Immunity General bacteriology and immunity

Topley   Wilson s Principles of Bacteriology  Virology  and Immunity  General bacteriology and immunity
  • Author : William Whiteman Carlton Topley,Sir Graham Selby Wilson
  • Publisher : Unknown
  • Release Date : 1990
  • Total pages : 468
  • ISBN : 0128094125
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Summary : Download or read online Topley Wilson s Principles of Bacteriology Virology and Immunity General bacteriology and immunity written by William Whiteman Carlton Topley,Sir Graham Selby Wilson, published by which was released on 1990. Get Topley Wilson s Principles of Bacteriology Virology and Immunity General bacteriology and immunity Books now! Available ...

Disinfection Sterilization and Preservation

Disinfection  Sterilization  and Preservation
  • Author : Seymour Stanton Block
  • Publisher : Williams & Wilkins
  • Release Date : 1991
  • Total pages : 1162
  • ISBN : 0128094125
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Summary : Now in its thoroughly revised, updated Fifth Edition, this volume is a comprehensive, practical reference on contemporary methods of disinfection, sterilization, and preservation and their medical, surgical, and public health applications. More than a third of this edition's chapters cover subjects never addressed in previous editions. New topics covered include ...

Intravenous Therapy

Intravenous Therapy
  • Author : Intravenous Nurses Society
  • Publisher : W.B. Saunders Company
  • Release Date : 1995
  • Total pages : 593
  • ISBN : 0128094125
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Summary : This text addresses special areas of IV therapy, including oncology and pain management, blood and blood components and parenteral nutrition. The book also offers calculations required for parenteral therapies and applies IV therapy to a variety of settings, including home health care and long-term care. in addition, it provides therapy ...