The Pharmaceutical Quality Control Handbook PDF Download
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Author: Rhys Bryant
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 232
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Book Description
Author: Rhys Bryant
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 232
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Book Description
Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
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Book Description
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Author: Ajit S. Narang
Publisher: Academic Press
ISBN: 0323481035
Category : Medical
Languages : en
Pages : 894
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Book Description
Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. - Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation - Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms - Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment
Author: Joseph A. Defeo
Publisher: McGraw-Hill Education
ISBN: 9781259643613
Category : Technology & Engineering
Languages : en
Pages : 0
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Book Description
Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. The cornerstone text on quality management and performance excellence – thoroughly revised to reflect the latest challenges and developments The “body of knowledge” for the science of quality management and performance excellence for more than half-a-century, Juran’s Quality Handbook has been completely updated to meet the ever-changing needs of today’s business and quality professionals. Under the guidance of a team of top experts, this authoritative resource demonstrates how to apply the right methods for delivering superior results and achieving excellence in any organization, industry, or country. Juran’s Quality Handbook, Seventh Edition provides you with a complete roadmap for the discipline -- clearly written to make sure you know where you are in the process and what you must do to reach the next level. Within its pages, you will find A-Z coverage – from key concepts, methods, research, and tools to practical applications on the job. Here’s why this is the best edition yet: • Updated chapters on Lean, Six Sigma and the Shingo Prize • NEW chapters on Risk Management and Building a Quality Management System • NEW material on the history of quality management • All ISO and other regulatory standards have been updated • NEW statistical tables, charts, and data • Examples and case studies throughout demonstrate how others have applied the methods and tools discussed in real-world situations
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128203331
Category : Science
Languages : en
Pages : 225
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Book Description
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Author: Eugenia Gabriela Carrillo-Cedillo
Publisher:
ISBN: 9781799896142
Category : Drugs
Languages : en
Pages :
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Book Description
"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards so as not to cause problems to the health of patients"--
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
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
Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 0123759811
Category : Medical
Languages : en
Pages : 604
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Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
