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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky
  • Publsiher : Academic Press
  • Release : 15 April 2019
  • ISBN : 0128094125
  • Pages : 208 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKPrinciples of Parenteral Solution Validation

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 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 : 15 April 2019
GET THIS BOOKPrinciples of Parenteral Solution Validation

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



Parenteral Medications, Fourth Edition

Parenteral Medications, Fourth Edition
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release : 19 July 2019
GET THIS BOOKParenteral Medications, Fourth Edition

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


Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release : 25 September 2007
GET THIS BOOKValidation of Pharmaceutical Processes

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




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 : 30 August 2019
GET THIS BOOKSolid Oral Dose Process Validation, Volume Two

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


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 : 16 November 2018
GET THIS BOOKSolid Oral Dose Process Validation

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



Sterile Product Development

Sterile Product Development
  • Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
  • Publisher : Springer Science & Business Media
  • Release : 12 October 2013
GET THIS BOOKSterile Product Development

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


How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release : 07 June 2016
GET THIS BOOKHow to Validate a Pharmaceutical Process

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


Particle Size Distribution II

Particle Size Distribution II
  • Author : American Chemical Society. Meeting
  • Publisher : Amer Chemical Society
  • Release : 03 March 1991
GET THIS BOOKParticle Size Distribution II

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, fractuals, electrophoretic characterization, image analysis, and electric sensing zone. A review chapter examines turbidimetry, an old technique that has been revitalized with new mathematical approaches. Of interest to coatings scientists;



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 : 03 March 2021
GET THIS BOOKBest Practices for Health-System Pharmacy 2003-2004

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: Positions and Guidance Documents of ASHP. These guidance documents have stimulated improvements in pharmacy practice and operations, influenced accreditation standards, laws, and regulations (both in the United States and in