Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Author: Hamid Mollah

Publisher: John Wiley & Sons

Published: 2013-03-18

Total Pages: 432

ISBN-13: 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.

Predictive Modeling of Pharmaceutical Unit Operations
Predictive Modeling of Pharmaceutical Unit Operations

Author: Preetanshu Pandey

Publisher: Woodhead Publishing

Published: 2016-09-26

Total Pages: 465

ISBN-13: 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

Pharmaceutical Microbiological Quality Assurance and Control
Pharmaceutical Microbiological Quality Assurance and Control

Author: David Roesti

Publisher: John Wiley & Sons

Published: 2020-01-02

Total Pages: 594

ISBN-13: 1119356075

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Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

ICH Quality Guidelines
ICH Quality Guidelines

Author: Andrew Teasdale

Publisher: John Wiley & Sons

Published: 2017-09-29

Total Pages: 624

ISBN-13: 1118971132

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Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Quality by Design for Biopharmaceuticals
Quality by Design for Biopharmaceuticals

Author: Anurag S. Rathore

Publisher: John Wiley & Sons

Published: 2011-09-20

Total Pages: 279

ISBN-13: 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.

Industrial Hygiene in the Pharmaceutical and Consumer Healthcare Industries
Industrial Hygiene in the Pharmaceutical and Consumer Healthcare Industries

Author: Casey C. Cosner

Publisher: CRC Press

Published: 2023-11-02

Total Pages: 179

ISBN-13: 1000983218

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This volume is an update on the use of containment in the pharmaceutical industry and consumer healthcare. It serves to highlight how industrial hygiene acts as a driving force within these industries to reduce the risk of exposure to chemical and physical agents, particularly to powders and dusts, while taking all factors into account. The author emphasizes how this book is not designed to replace other texts on containment; rather, it will serve to show a practical approach of utilizing the technologies within the high-demand industries of pharmaceuticals and consumer healthcare. Features: Timely coverage of changes in process control technology for the phamaceutical industry, a dynamic area in terms of products and manufacturing processes Provides an update on the unique requirements of these industries and how they differ from others, for example the microelectronics or specialized chemicals industries Draws on the author's vast experience in the field of industrial hygiene and hazardous materials Presents a collection of unique situations in which industrial hygiene was implemented to resolve a variety of scenarios and did not interfere with quality issues Addresses current topics relating to industry evolution such as migration of therapies to higher potency, RiskMAP, new modalities in medicines and treatments, large molecule therapeutics and conjugates

Pharmaceutical Quality by Design
Pharmaceutical Quality by Design

Author: Sarwar Beg

Publisher: Academic Press

Published: 2019-03-27

Total Pages: 450

ISBN-13: 0128163720

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Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Biopharmaceutical Production Technology
Biopharmaceutical Production Technology

Author: Ganapathy Subramanian

Publisher: John Wiley & Sons

Published: 2012-05-14

Total Pages: 945

ISBN-13: 3527653112

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Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry
A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Author: Nuala Calnan

Publisher: CRC Press

Published: 2017-06-26

Total Pages: 357

ISBN-13: 1315351366

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This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

Pharmaceutical Computer Systems Validation
Pharmaceutical Computer Systems Validation

Author: Guy Wingate

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 773

ISBN-13: 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.