Principles of Parenteral Solution Validation Book

Principles of Parenteral Solution Validation


  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Release Date : 2019-04-15
  • Genre: Medical
  • Pages : 208
  • ISBN 10 : 9780128094129

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Principles of Parenteral Solution Validation 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 Book

Principles of Parenteral Solution Validation


  • Author : Igor Gorsky
  • Publisher : Academic Press
  • Release Date : 2019-11-27
  • Genre: Medical
  • Pages : 298
  • ISBN 10 : 9780128094464

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Principles of Parenteral Solution Validation 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

How to Develop Robust Solid Oral Dosage Forms Book

How to Develop Robust Solid Oral Dosage Forms


  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2016-10-05
  • Genre: Medical
  • Pages : 190
  • ISBN 10 : 9780128047323

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How to Develop Robust Solid Oral Dosage Forms Excerpt :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book

Handbook of Validation in Pharmaceutical Processes Fourth Edition


  • Author : James Agalloco
  • Publisher : CRC Press
  • Release Date : 2021-10-28
  • Genre: Medical
  • Pages : 1061
  • ISBN 10 : 9781000436013

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Handbook of Validation in Pharmaceutical Processes Fourth Edition Excerpt :

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

Pharmaceutical Process Validation  Second Edition Book

Pharmaceutical Process Validation Second Edition


  • Author : Ira R. Berry
  • Publisher : CRC Press
  • Release Date : 1993-01-29
  • Genre: Medical
  • Pages : 602
  • ISBN 10 : UOM:39015029467159

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Pharmaceutical Process Validation Second Edition Excerpt :

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.

Pharmaceutical Process Validation Book

Pharmaceutical Process Validation


  • Author : Bernard T. Loftus
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1984
  • Genre: Medical
  • Pages : 286
  • ISBN 10 : UOM:39015006032687

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Pharmaceutical Process Validation Excerpt :

Modern Pharmaceutics Volume 1 Book

Modern Pharmaceutics Volume 1


  • Author : Alexander T. Florence
  • Publisher : CRC Press
  • Release Date : 2009-05-28
  • Genre: Medical
  • Pages : 656
  • ISBN 10 : 9781420065657

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Modern Pharmaceutics Volume 1 Excerpt :

With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics. Key topics in Volume 1 include: • principles of drug absorption, chemical kinetics, and drug stability • pharmacokinetics • the effect of route of administration and distribution on drug action • in vivo imaging of dose forms: gamma scintigraphy, PET imaging NMR, MRI, etc. • powder technology • excipient design and characterization • preformulation • optimization techniques in pharmaceutical formulation and processing • disperse and surfactant systems • the solid state, tablet dosage forms, coating processes, and hard and soft shell capsules • parenteral products

Parenteral Medications  Fourth Edition Book

Parenteral Medications Fourth Edition


  • Author : Sandeep Nema
  • Publisher : CRC Press
  • Release Date : 2019-07-19
  • Genre: Business & Economics
  • Pages : 1125
  • ISBN 10 : 9780429576836

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Parenteral Medications Fourth Edition Excerpt :

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 Book

Sterile Product Development


  • Author : Parag Kolhe
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-10-12
  • Genre: Medical
  • Pages : 585
  • ISBN 10 : 9781461479789

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Sterile Product Development Excerpt :

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.

21 CFR Part 11 Book

21 CFR Part 11


  • Author : Orlando López
  • Publisher : CRC Press
  • Release Date : 2004-01-15
  • Genre: Medical
  • Pages : 243
  • ISBN 10 : 9781135488758

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21 CFR Part 11 Excerpt :

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

Parenteral Quality Control Book
Score: 4
From 1 Ratings

Parenteral Quality Control


  • Author : Michael K. Akers
  • Publisher : CRC Press
  • Release Date : 2002-11-20
  • Genre: Medical
  • Pages : 401
  • ISBN 10 : 9780824745660

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Parenteral Quality Control Excerpt :

Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to test

Epidemiology and Prevention of Vaccine Preventable Diseases  13th Edition E Book Book

Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book


  • Author : Jennifer Hamborsky, MPH, MCHES
  • Publisher : Public Health Foundation
  • Release Date : 2015-10-19
  • Genre: Health & Fitness
  • Pages : 512
  • ISBN 10 : 9780990449126

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Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book Excerpt :

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact bookstore@phf.org for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

Validation Standard Operating Procedures Book
Score: 2
From 3 Ratings

Validation Standard Operating Procedures


  • Author : Syed Imtiaz Haider
  • Publisher : CRC Press
  • Release Date : 2006-05-30
  • Genre: Medical
  • Pages : 1144
  • ISBN 10 : 9781420009415

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Validation Standard Operating Procedures Excerpt :

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