[PDF] Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing eBook

Author : Hamid Mollah
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 32,65 MB
Release : 2013-03-18
Category : Science
ISBN : 0470552344

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Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Author : Zbigniew J. Witczak
Publisher : Wiley
Page : 400 pages
File Size : 45,12 MB
Release : 2013-02-05
Category : Science
ISBN : 9781118526934

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Lays the foundation for new methods and applications of carbohydrate click chemistry Introduced by K. Barry Sharpless of The Scripps Research Institute in 2001, click chemistry mimics nature, giving researchers the tools needed to generate new substances quickly and reliably by joining small units together. With contributions from more than thirty pioneering researchers in the field, this text explores the many promising applications of click chemistry in glycoscience. Readers will learn both the basic concepts of carbohydrate click chemistry as well as its many biomedical applications, including synthetic antigens, analogs of cell-surface receptors, immobilized enzymes, targeted drug delivery systems, and multivalent cancer vaccines. Click Chemistry in Glycoscience examines a broad range of methodologies and strategies that have emerged from this rapidly evolving field. Each chapter describes new approaches, ideas, consequences, and applications resulting from the introduction of click processes. Divided into four sections, the book covers: Click chemistry strategies and decoupling Thio-click chemistry of carbohydrates Carbohydrate click chemistry for novel synthetic targets Carbohydrate click chemistry in biomedical sciences Thoroughly researched, the book reflects the most recent findings published in the literature. Diagrams and figures throughout the book enable readers to more easily grasp complex concepts and reaction processes. At the end of each chapter, references lead to the primary literature for further investigation of individual topics. The application of click chemistry to carbohydrates has tremendous implications for research. With this book as their guide, researchers have a solid foundation from which they can develop new methods and applications of carbohydrate click chemistry, including new carbohydrate-based therapeutics.

Author : Anurag S. Rathore
Publisher : John Wiley & Sons
Page : 279 pages
File Size : 42,47 MB
Release : 2011-09-20
Category : Science
ISBN : 1118210913

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The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Author : Guy Wingate
Publisher : CRC Press
Page : 773 pages
File Size : 47,79 MB
Release : 2016-04-19
Category : Medical
ISBN : 1420088955

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Author : Jose (Pepe) Rodriguez-Perez
Publisher : Quality Press
Page : 313 pages
File Size : 17,92 MB
Release : 2024-04-18
Category : Business & Economics
ISBN : 1636941567

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For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.

Author : Dr Tim Sandle
Publisher : Createspace Independent Publishing Platform
Page : 168 pages
File Size : 21,55 MB
Release : 2013-06-01
Category : Science
ISBN : 9781482596144

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This book presents an overview of risk management and risk assessment for those working in the pharmaceutical and healthcare sectors. An understanding of risk management and risk assessment is today becoming a prerequisite for those working in quality control and quality assurance, and for those active in pharmaceuticals and medical devices, Quality Risk Management it is a mandatory requirement. The book expands upon this subject through a series of case studies, utilizing tools like HACCP and FMEA.

Author : David Robert Linders
Publisher :
Page : 139 pages
File Size : 50,23 MB
Release : 2013
Category :
ISBN :

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Injectable drugs, like those manufactured by the BioPharmOps group of Novartis Pharmaceuticals AG, must conform to strict guidelines for purity and potency. Recent non-conformances of critical supplied consumables have revealed potential business and patient safety risks for biotechnology manufacturers worldwide. As a result, Novartis has launched a program to enhance control systems over all consumables and their suppliers. Within this program, the author has developed a system to identify, analyze, and mitigate the various risks which may impact the business due to non-conformances in supplied consumables. The first function of the system is the identification of key risks and their potential effects according to various failure modes that have been observed during the use of the consumables in production. This is accomplished with a standardized list of possible failure modes which can be applied to all consumables. The categorization allows the relative risk of each failure mode to be compared among consumables. Secondly, the risk of contamination is evaluated using a Failure Modes and Effects Analysis (FMEA) framework. The three dimensions of the FMEA framework are the severity, likelihood, and detectability of a failure. The severity of each failure mode is assessed by analyzing the quantitative and qualitative impact that a failure might have on the purity and potency of the drug. This calculation is based on the properties of each consumable and its use in the production system. The likelihood of failure events is assessed through an analysis of the complexity of the consumable and its supply chain, and a review of the quality systems at the supplier. Detectability analysis considers the tests and inspections in place at various stages including consumable manufacturing, receiving inspection, and in-process tests during drug manufacturing which could detect a non-conformance. The total risk level is evaluated as the product of these three dimensions and a threshold is defined for requiring additional mitigations for these risks. This risk assessment method is implemented in an automated worksheet to ensure consistency among users and efficient analysis. The third outcome of the system is the recommendation of mitigations to reduce total exposure to contamination risk. Mitigations may be internal (new tests and inspections) or implemented at the supplier (improved sampling rates, enhanced general quality systems, or new controls). The recommended mitigations provide guidance for the reduction of risks to an acceptable level, and when implemented, the impact and frequency of non-conformances will be diminished. Ultimately, this reduces Novartis' exposure to potential business loss and protects patients from injury caused by contamination.

Author : Preetanshu Pandey
Publisher : Woodhead Publishing
Page : 465 pages
File Size : 18,64 MB
Release : 2016-09-26
Category : Medical
ISBN : 0081001800

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The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points