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Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
A Practical Lifecycle Approach

by Igor Gorsky,Harold S. Baseman

  • Publisher : Academic Press
  • Release : 2019-04-15
  • Pages : 208
  • ISBN : 0128094125
  • 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
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1987
  • Pages : 25
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Parenteral Medications, Fourth Edition

Parenteral Medications, Fourth Edition
A Book

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2019-07-19
  • Pages : 1125
  • ISBN : 0429576838
  • 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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
A Book

by James P. Agalloco,Frederick J. Carleton

  • Publisher : CRC Press
  • Release : 2007-09-25
  • Pages : 760
  • ISBN : 9781420019797
  • Language : En, Es, Fr & De
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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
A Book

by Ira R. Berry,Robert A. Nash

  • Publisher : CRC Press
  • Release : 1993-01-29
  • Pages : 602
  • ISBN : 9876543210XXX
  • 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.

Pharmaceutical Process Validation

Pharmaceutical Process Validation
A Book

by Bernard T. Loftus,Robert A. Nash

  • Publisher : Marcel Dekker Incorporated
  • Release : 1984
  • Pages : 286
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Principles of Sterile Product Preparation

Principles of Sterile Product Preparation
A Book

by E. Clyde Buchanan

  • Publisher : Amer Soc of Health System
  • Release : 1995
  • Pages : 182
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Solid Oral Dose Process Validation, Volume Two

Solid Oral Dose Process Validation, Volume Two
Lifecycle Approach Application

by Ajay Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Marzena Ingram,Jordan Collins

  • Publisher : Springer Nature
  • Release : 2019-08-30
  • Pages : 108
  • ISBN : 3030274845
  • Language : En, Es, Fr & De
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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 available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.

Solid Oral Dose Process Validation

Solid Oral Dose Process Validation
The Basics

by Ajay Babu Pazhayattil,Naheed Sayeed-Desta,Emilija Fredro-Kumbaradzi,Jordan Collins

  • Publisher : Springer
  • Release : 2018-11-16
  • Pages : 92
  • ISBN : 3030024725
  • Language : En, Es, Fr & De
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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 companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

Validation of Aseptic Pharmaceutical Processes

Validation of Aseptic Pharmaceutical Processes
A Book

by Frederick J. Carleton,James P. Agalloco

  • Publisher : Marcel Dekker
  • Release : 1986
  • Pages : 696
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Sterile Product Development

Sterile Product Development
Formulation, Process, Quality and Regulatory Considerations

by Parag Kolhe,Mrinal Shah,Nitin Rathore

  • Publisher : Springer Science & Business Media
  • Release : 2013-10-12
  • Pages : 585
  • ISBN : 1461479789
  • Language : En, Es, Fr & De
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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.

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
A Book

by Tim Sandle

  • Publisher : Academic Press
  • Release : 2018-11-30
  • Pages : 374
  • ISBN : 0128149124
  • Language : En, Es, Fr & De
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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
A Book

by Steven Ostrove

  • Publisher : Academic Press
  • Release : 2016-06-07
  • Pages : 218
  • ISBN : 0128096535
  • Language : En, Es, Fr & De
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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 engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

Pharmaceutical Dosage Forms - Parenteral Medications

Pharmaceutical Dosage Forms - Parenteral Medications
Volume 3: Regulations, Validation and the Future

by Sandeep Nema,John D. Ludwig

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 318
  • ISBN : 1420086480
  • Language : En, Es, Fr & De
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This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, and will also serve as an excellent reference and training tool for regulatory scientists and quality assurance professionals. First published in 1984 (as two volumes) and then last revised in 1993 (when it grew to three volumes), this latest revision will address the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. The third edition of this book maintains the features that made the last edition so popular but comprises several brand new chapters, revisions to all other chapters, as well as high quality illustrations. Volume three presents: • An in-depth discussion of regulatory requirements, quality assurance, risk assessment and mitigation, and extractables/leachables. • Specific chapters on parenteral administrations devices, injection site pain assessment, and parenteral product specifications and stability testing. • Forward-thinking discussions on the future of parenteral product manufacturing, and siRNA delivery systems. • New chapters covering recent developments in the areas of visual inspection, quality by design (QbD), process analytical technology (PAT) and rapid microbiological methods (RMM ), and validation of drug product manufacturing process.

Sterile Drug Products

Sterile Drug Products
Formulation, Packaging, Manufacturing and Quality

by Michael J. Akers

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 516
  • ISBN : 1420020560
  • Language : En, Es, Fr & De
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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.

Particle Size Distribution II

Particle Size Distribution II
Assessment and Characterization

by American Chemical Society. Meeting

  • Publisher : Amer Chemical Society
  • Release : 1991
  • Pages : 407
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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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; colloid and surface chemists; and polymer, physical, and analytical chemists.

Pharmaceutical Facilities

Pharmaceutical Facilities
Design, Layouts and Validation

by Manohar A Potdar

  • Publisher : Unknown Publisher
  • Release : 2014-11
  • Pages : 306
  • ISBN : 9789385433764
  • Language : En, Es, Fr & De
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Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry. Salient Features: - Pharmaceutical design aspects with sample layouts for all major formulations are discussed - All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed - A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.

Best Practices for Hospital & Health-system Pharmacy

Best Practices for Hospital & Health-system Pharmacy
Position and Guidance Documents of ASHP.

by American Society of Health-System Pharmacists

  • Publisher : Unknown Publisher
  • Release : 2007
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Best Practices for Health-System Pharmacy

Best Practices for Health-System Pharmacy
Positions and Guidance Documents of ASHP, 2004-2005

by Bruce Hawkins

  • Publisher : Amer Soc of Health System
  • Release : 2004
  • Pages : 642
  • ISBN : 9781585281107
  • Language : En, Es, Fr & De
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Best Practices for Health-System Pharmacy 2003-2004

Best Practices for Health-System Pharmacy 2003-2004
Positions and Guidance Documents of ASHP

by American Society of Health-System Pharmacists

  • Publisher : Amer Soc of Health System
  • Release : 2003
  • Pages : 638
  • ISBN : 9781585280551
  • Language : En, Es, Fr & De
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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 other countries), and contributed to an awareness among consumers and policymakers of the vital patient care role of pharmacists. Substantial content has been added or revised since the release of the 2002-2003 edition, including new material relating to the pharmacist's role in immunization, use of statins in the prevention of atherosclerotic vascular disease, documenting pharmaceutical care in the patient medical record, strict glycemic control in patients with diabetes, and the recruitment, selection, and retention of pharmacy personnel. Book jacket.