Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. - Contains the applications of pharmaceutical microbiology in sterile and non-sterile products - Presents the practical aspects of pharmaceutical microbiology testing - Provides contamination control risks and remediation strategies, along with rapid microbiological methods - Includes bioburden, endotoxin, and specific microbial risks - Highlights relevant case studies and risk assessment scenarios

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy

Download or read book Performance Metrics written by Duke Okes and published by Quality Press. This book was released on 2013-01-21 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: Which performance measures should you use? The obvious answer is that it depends on what you want to achieve, which someone else should never define for you. After all, it is your organization, your department, or your process. But once you are clear about what you want to accomplish, how do you sort through a variety of possible metrics and decide which are best? Then, given the list of metrics you believe are useful or necessary, how do you define them in more detail to ensure that the right data are gathered at the appropriate frequency and that the resulting information gets to the right people so that they can make proper decisions? This book provides a clarifying perspective for those who know that metrics need to be developed but are unsure as to the steps to follow in developing and deploying them. It focuses on making sure that the metrics selected will guide people and processes in the direction the organization wants to go, and allow continual evaluation of success. Every highly effective organization is unique in some strategic way, and the metrics used should reflect these differences. Studying high performers can be useful from a learning standpoint, but simply adopting what someone else is doing is likely to take you off your track and put you on theirs. The concepts in this book will put you on the correct track and give you the tools to stay on it.

Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Sterility Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. - Covers the main sterilisation methods of physical removal, physical alteration and inactivation - Includes discussion of medical devices, aseptically filled products and terminally sterilised products - Describes bacterial, pyrogenic, and endotoxin risks to devices and products

Download or read book A Handbook of Artificial Intelligence in Drug Delivery written by Anil K. Philip and published by Academic Press. This book was released on 2023-03-27 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Handbook of Artificial Intelligence in Drug Delivery explores the use of Artificial Intelligence (AI) in drug delivery strategies. The book covers pharmaceutical AI and drug discovery challenges, Artificial Intelligence tools for drug research, AI enabled intelligent drug delivery systems and next generation novel therapeutics, broad utility of AI for designing novel micro/nanosystems for drug delivery, AI driven personalized medicine and Gene therapy, 3D Organ printing and tissue engineering, Advanced nanosystems based on AI principles (nanorobots, nanomachines), opportunities and challenges using artificial intelligence in ADME/Tox in drug development, commercialization and regulatory perspectives, ethics in AI, and more. This book will be useful to academic and industrial researchers interested in drug delivery, chemical biology, computational chemistry, medicinal chemistry and bioinformatics. The massive time and costs investments in drug research and development necessitate application of more innovative techniques and smart strategies. - Focuses on the use of Artificial Intelligence in drug delivery strategies and future impacts - Provides insights into how artificial intelligence can be effectively used for the development of advanced drug delivery systems - Written by experts in the field of advanced drug delivery systems and digital health

Download or read book HVAC Site Acceptance Testing for Pharmaceutical Plants Ensuring Quality Compliance and Efficiency written by Charles Nehme and published by Charles Nehme. This book was released on with total page 63 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preface for HVAC Site Acceptance Test for Pharmaceutical Plants Introduction The HVAC (Heating, Ventilation, and Air Conditioning) systems play a crucial role in pharmaceutical plants, ensuring that environmental conditions are tightly controlled to meet stringent regulatory requirements. The integrity of these systems directly impacts the quality and safety of pharmaceutical products. Therefore, a thorough and meticulously documented site acceptance test (SAT) is essential before commissioning any HVAC system in a pharmaceutical plant. Purpose The purpose of this document is to outline the procedures and criteria for conducting the HVAC site acceptance test (SAT) in pharmaceutical plants. The SAT ensures that the installed HVAC system operates according to the specified design, meets regulatory standards, and fulfills the requirements for maintaining controlled environments critical for pharmaceutical production. Scope This document covers the SAT procedures for HVAC systems, including testing methodologies, performance criteria, documentation requirements, and acceptance standards. It is intended for use by project managers, validation engineers, quality assurance personnel, and HVAC contractors involved in the commissioning and qualification of HVAC systems in pharmaceutical plants. Importance of HVAC Systems in Pharmaceutical Plants Environmental Control: HVAC systems maintain temperature, humidity, and air quality within specified ranges, essential for product stability and compliance with good manufacturing practices (GMP). Contamination Control: Properly functioning HVAC systems prevent cross-contamination and ensure a sterile environment, which is vital for the production of drugs and medical products. Regulatory Compliance: Compliance with regulatory standards, such as those set by the FDA, EMA, and other global health authorities, is mandatory for pharmaceutical plants. The SAT is a critical step in demonstrating that the HVAC system meets these stringent requirements. Product Quality: The consistent operation of HVAC systems is essential to ensure the quality and efficacy of pharmaceutical products. Any deviations can lead to compromised product integrity and potential recalls. Objectives The primary objectives of the HVAC SAT are: Verification of System Installation: Ensure that the HVAC system is installed according to design specifications and manufacturer guidelines. Operational Performance Testing: Validate that the HVAC system operates within specified parameters for temperature, humidity, airflow, and filtration. Compliance with Regulations: Confirm that the HVAC system meets all relevant regulatory standards and guidelines. Documentation and Reporting: Provide comprehensive documentation and reports to support the validation process and facilitate regulatory inspections. Structure of the Document This document is structured as follows: Preparation for SAT: Overview of pre-test preparations, including reviewing design specifications, regulatory requirements, and preparing test protocols. SAT Procedures: Detailed procedures for conducting the SAT, including test methods, instrumentation, and data collection. Performance Criteria: Specification of the performance criteria and acceptable limits for various parameters such as temperature, humidity, and airflow. Documentation Requirements: Guidelines for documenting the SAT process, including test results, deviations, and corrective actions. Acceptance and Approval: Criteria for acceptance and the process for approval by relevant stakeholders. Conclusion The HVAC site acceptance test is a critical component in the commissioning of pharmaceutical plants, ensuring that the environmental conditions necessary for product quality and regulatory compliance are met. This document provides a comprehensive framework for conducting the SAT, emphasizing the importance of meticulous testing and documentation to achieve a validated and reliable HVAC system.

Download or read book Achieving Regulatory Excellence written by Cary Coglianese and published by Brookings Institution Press. This book was released on 2016-12-20 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.

Download or read book MODERN PHARMACEUTICS written by Dr. Ananda Kumar Chettupalli, Mrs. J. K. Shyamala, Ms. Jyoti Verma, Prof. Bibhuti Bhusana Panigrahi, Dr. Nilima Shukla and published by Shashwat Publication. This book was released on 2024-08-07 with total page 471 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the previous few decades, the discipline of pharmaceutics has experienced substantial change. Today, more than ever, a thorough understanding of current pharmaceutics is required as the research pertaining to medication transport and formulation advances. For those studying, teaching, or working in the pharmaceutical sciences, this textbook, "Modern Pharmaceutics," is a vital tool. Gaining a comprehensive grasp of the concepts and applications of contemporary pharmaceutics is the aim of this course. This book offers a comprehensive yet fair review of the subject, covering everything from the fundamentals of drug delivery systems to the most recent developments in pharmaceutical technology. In order to help the reader navigate the complexity of pharmaceutics, the chapters in this book are carefully arranged. The book begins with the fundamental notions and moves on to more complex subjects, providing a thorough and progressive learning experience. Drug delivery methods, pharmaceutical formulations, cutting-edge technology, and ethical and regulatory issues are important areas of study. The emphasis in this work is on applying theoretical knowledge in real-world situations.

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Auditing for Environmental Quality Leadership written by Environmental Auditing Roundtable and published by . This book was released on 1995-04-17 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many of the best and most successful companies are no longer content to do the minimum required to achieve compliance with environmental regulations. Instead, a new standard of environmental excellence has arisen. A high-quality environmental system is now seen both as a means to regulatory compliance and as a very cost-effective way of increasing the efficiency and effectiveness of operations in general. In this way, the environmental audit often serves as a significant driver for improvement within the overall management system. Auditing for Environmental Quality Leadership details these new techniques and practices in environmental auditing and shows how their place in a Total Quality Environmental Management System can help companies achieve environmental excellence and a competitive advantage. Sponsored by the Environmental Auditing Roundtable, this book covers the major topics in defining, conducting, assessing, and improving an environmental audit. Unique in its breadth and depth of coverage, this book includes: Comprehensive treatment of environmental auditing by recognized leaders in the field Application of Total Quality Environmental Management methods to develop efficient environmental auditing programs that delve into root causes and sort out what adds value from what does not Analysis of the movement toward standardization of environmental auditing principles and practices, including such timely international issues as efforts to produce North American standards, the European Eco-label and Audit scheme, and the International Standard Organization's ISO 9000 and 14000 series Examination of innovative auditing programs developed by leading corporations and trade organizations, including Allied Signal, Union Carbide, Lockheed, and many others Latest methods of information management technology and automated auditing for assembling, auditing, and reviewing environmental data Because of its thorough, authoritative examination of the issues, illuminating case studies, and wealth of practical guidance, environmental professionals and corporate and government managers will find Auditing for Environmental Quality Leadership essential reading on this crucial topic. Auditing for Environmental Quality Leadership Beyond Compliance to Environmental Excellence To meet the challenges of regulatory compliance, international standards, and the need to "work smarter" in today's marketplace, greater emphasis is being placed on environmental auditing—especially among the most forward-looking companies. In this book, you will find a comprehensive presentation of the entire field of environmental auditing by leading experts in the field. It covers the latest practices and shows, through specific case studies, how major corporations are applying them to achieve environmental excellence and competitive advantage. Sponsored by the Environmental Auditing Roundtable, this book covers the major procedures used in defining, conducting, assessing, and improving an environmental auditing program. Such timely and important subjects as Total Quality Environmental Management, the internationalization of standards, and the use of information technology are clearly presented and explored. Auditing for Environmental Quality Leadership will give managers, consultants, and environmental professionals authoritative guidance in this increasingly important field.

Download or read book Good Research Practice in Non Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Download or read book GMP Compliance Productivity and Quality written by Vinay Bhatt and published by CRC Press. This book was released on 1998-06-30 with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and co

Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.