Advertisement
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-04-04 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. |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-03-17 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. |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-03-24 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. |
| pharmaceutical manufacturing handbook regulations and quality: Good Manufacturing Practices for Pharmaceuticals, Seventh Edition Graham P. Bunn, 2019-02-04 This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. |
| pharmaceutical manufacturing handbook regulations and quality: Regulatory Affairs in the Pharmaceutical Industry Javed Ali, Sanjula Baboota, 2021-11-14 Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Quality Systems Oliver Schmidt, 2000-04-30 When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a pr |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Stability Testing in Pharmaceutical Development Kim Huynh-Ba, 2008-11-16 This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices. |
| pharmaceutical manufacturing handbook regulations and quality: Good Manufacturing Practices for Pharmaceuticals Joseph D. Nally, 2016-04-19 With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Pharmaceutical Manufacturing Formulations Safaraz K. Niazi, 2016-04-19 No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Excipients Otilia M. Y. Koo, 2016-10-31 This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients |
| pharmaceutical manufacturing handbook regulations and quality: Good Manufacturing Practices for Pharmaceuticals D. Nally Joseph, 2000-10-12 Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers. |
| pharmaceutical manufacturing handbook regulations and quality: Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry Eugenia Gabriela Carrillo-Cedillo, Karina Cecilia Arredondo-Soto, Kenia Palomino Vizcaino, Héctor Magaña Badilla, 2022 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-- |
| pharmaceutical manufacturing handbook regulations and quality: Practical Pharmaceutical Engineering Gary Prager, 2018-11-28 A practical guide to all key the elements of pharmaceuticals and biotech manufacturing and design Engineers working in the pharmaceutical and biotech industries are routinely called upon to handle operational issues outside of their fields of expertise. Traditionally the competencies required to fulfill those tasks were achieved piecemeal, through years of self-teaching and on-the-job experience—until now. Practical Pharmaceutical Engineering provides readers with the technical information and tools needed to deal with most common engineering issues that can arise in the course of day-to-day operations of pharmaceutical/biotech research and manufacturing. Engineers working in pharma/biotech wear many hats. They are involved in the conception, design, construction, and operation of research facilities and manufacturing plants, as well as the scale-up, manufacturing, packaging, and labeling processes. They have to implement FDA regulations, validation assurance, quality control, and Good Manufacturing Practices (GMP) compliance measures, and to maintain a high level of personal and environmental safety. This book provides readers from a range of engineering specialties with a detailed blueprint and the technical knowledge needed to tackle those critical responsibilities with confidence. At minimum, after reading this book, readers will have the knowledge needed to constructively participate in contractor/user briefings. Provides pharmaceutical industry professionals with an overview of how all the parts fit together and a level of expertise that can take years of on-the-job experience to acquire Addresses topics not covered in university courses but which are crucial to working effectively in the pharma/biotech industry Fills a gap in the literature, providing important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering Covers the basics of HVAC systems, water systems, electric systems, reliability, maintainability, and quality assurance, relevant to pharmaceutical engineering Practical Pharmaceutical Engineering is an indispensable “tool of the trade” for chemical engineers, mechanical engineers, and pharmaceutical engineers employed by pharmaceutical and biotech companies, engineering firms, and consulting firms. It also is a must-read for engineering students, pharmacy students, chemistry students, and others considering a career in pharmaceuticals. |
| pharmaceutical manufacturing handbook regulations and quality: Quality Control Training Manual Syed Imtiaz Haider, Syed Erfan Asif, 2016-04-19 Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying downloadable resources comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries Includes downloadable resources with downloadable training courses that can be adopted and directly customized to a particular organization Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the downloadable resources supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance. |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Quality by Design Walkiria S. Schlindwein, Mark Gibson, 2018-03-19 A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products. |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Quality Assurance Mr. Manohar A. Potdar, 2006 |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Computer Systems Validation Guy Wingate, 2016-04-19 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. |
| pharmaceutical manufacturing handbook regulations and quality: Corporate Crime in the Pharmaceutical Industry (Routledge Revivals) John Braithwaite, 2013-10-08 First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally. |
| pharmaceutical manufacturing handbook regulations and quality: Good Manufacturing Practices for Pharmaceuticals B. N. Cooper, 2017-07-26 CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8 x 10 format |
| pharmaceutical manufacturing handbook regulations and quality: Current Good Manufacturing Practices Mindy J. Allport-Settle, 2018-02-20 FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) - Part 200 Drugs: General (21CFR§200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) - Part 600 Biological Products: General (21CFR§600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) - Part 820 Quality System Regulation (21CFR§820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents |
| pharmaceutical manufacturing handbook regulations and quality: Good Clinical, Laboratory and Manufacturing Practices Philip Carson, Nigel Dent, 2007-10-31 Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included. |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Radiopharmaceuticals Michael R. Kilbourn, Peter J. H. Scott, 2021-04-12 Sorgfältig aktualisierte Neuauflage dieses wegweisenden Referenzwerk der radiopharmazeutischen Wissenschaften Die 2. Auflage des Handbook of Radiopharmaceuticals wirft einen umfassenden analytischen Blick auf das Fachgebiet und bietet aktuelle Informationen zu zentralen Themen, u. a. die Herstellung von Radionukliden, synthetische Methoden, Entwicklungen in der Radiopharmazie, Regelwerke, und zu einer Fülle praktischer Anwendungen. Als wertvolles Nachschlagewerk für Einsteiger und erfahrene Praktiker untersucht diese Publikation die neuesten Konzepte und Fragestellungen unter Berücksichtigung des gezielten Einsatzes diagnostischer und therapeutischer Radiopharmazeutika. Die Beiträge stammen von Experten verschiedenster Unterdisziplinen und lassen den Leser eintauchen in die Radiochemie, Nuklearmedizin, molekulare Bildgebung u.v.m. Die Nuklearmedizin und radiopharmazeutischen Wissenschaften haben sich seit Veröffentlichung der 1. Auflage stark verändert. Neue Radiopharmazeutika für Diagnostik und Therapie wurden von der FDA zugelassen, klinische PET- und SPECT-Scans haben drastisch zugenommen und Fortschritte im Bereich Künstliche Intelligenz haben zu signifikant verbesserten Forschungsverfahren geführt. Diese vollständig überarbeitete Auflage stellt den derzeitigen Erkenntnisstand des Fachgebiets vor, ergänzt um aktualisierte und neue Inhalte. Neue Kapitel beschäftigen sich mit heutigen Good Manufacturing Practice, regulatorischen Entwicklungen und neuen Ansätzen bei der Qualitätskontrolle. Damit wird sichergestellt, dass die Leserschaft über die aufregenden Entwicklungen der letzten Jahre rundum im Bilde ist. Dieses wichtige Referenzwerk - bietet durchgängig neue und überarbeitete Inhalte. - deckt zentrale Anwendungsbereiche in der Diagnostik und Therapie ab, für die Onkologie, Neurologie und Kardiologie. - unterstreicht die multidisziplinäre Ausrichtung der radiopharmazeutischen Wissenschaften. - zeigt, wie Pharmaunternehmen mit modernen Bildgebungsverfahren der Radiopharmazie neue Medikamente entwickeln. - untersucht heutige und neue Anwendungen der Positronen-Emissions-Tomographie (PET) und Single-Photonen-Emissions-Computertomographie (SPECT). Die Herausgeber sind anerkannte Experten der Fachrichtungen Radiochemie und PET-Bildgebung. Die 2. Auflage des Handbook of Radiopharmaceuticals: Radiochemistry and Applications ist ein Muss für Postdoktoranden, Forscher und Fachexperten in der Pharmazeutischen Industrie und richtet sich ebenso an die akademische Forschung und Lehre, an Graduierte und Einsteiger in das Fachgebiet der Radiopharmazeutika. |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Pharmaceutical Biotechnology Jay P Rho, Stan G Louie, 2003-04-02 This compendium of drugs produced by biotechnology covers general principles of biotechnology and pharmaceuticals. Descriptions of each type of drug break down each product by pharmacology, toxicities, pharmacokinetics, clinical applications, and dosage guides. There are also reviews of prescription. |
| pharmaceutical manufacturing handbook regulations and quality: Good Manufacturing Practice (GMP) Guidelines Mindy J. Allport-Settle, 2009-12 This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union. |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Validation in Pharmaceutical Processes, Fourth Edition James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, 2021-10-28 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 |
| pharmaceutical manufacturing handbook regulations and quality: Quality Culture in the Pharmaceutical Industry Jose (Pepe) Rodríguez-Pérez, 2021-03-19 Why so many pharmaceutical companies are struggling to meet GMP and other regulatory requirements?The reason is clear: because they are trying to improve their quality management systems by fixing symptoms rather than by attacking the fundamental and primary root cause of their problems which is the lack of adequate quality and compliance culture.The purpose of this book is to provide those leaders and senior managers with a clear roadmap to solve their regulatory problems and to return to the route of compliance by implementing a strong, positive quality and compliance culture. The recipe is simple: all you need is good people (including good leaders and senior managers), good procedures and good training programs sailing into a strong and positive culture of quality and compliance.When a company implements a behavior-based quality and culture compliance, they look into their problems as a whole, and they understand that there are multiple factors (including the soft ones related to personal and organizational behaviors) that affect performance. A very positive consequence of this systematic thinking is the shift from CAPA programs mostly correctives to ones where the systemic preventive actions are predominant.Quality is everyone's responsibility, but when it comes to creating, strengthening, or maintaining a culture within an organization, there is one group who really owns it: the leaders and senior managers.The good news is that creating or strengthening a positive and sustainable quality culture is an achievable task although not an easy or quick one. In this book you will find ten foundational principles of a strong and positive quality culture, their associated desired behaviors and a set of leading indicators that can be used to monitor and enhance leadership engagement, people engagement, and culture and maturity. |
| pharmaceutical manufacturing handbook regulations and quality: Handbook of Pharmaceutical Excipients Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn, 2009 Describes the chemical and physical properties of pharmaceutical excipients. Each monograph contains nonproprietary names, synonyms, chemical name and CAS registry number, empirical formula and molecular weight, structural formula, functional category, applications in pharmaceutical formulation or technology, description, pharmacopeial specifications, typical propertics, stability and storage conditions, incompatibilities, method of manufacture, safety, handling precautions, regulatory status, pharmacopeias, related substances, comments, specific references, general references, and authors. |
| pharmaceutical manufacturing handbook regulations and quality: Good Research Practice in Non-Clinical Pharmacology and Biomedicine Anton Bespalov, Martin C. Michel, Thomas Steckler, 2020-02-20 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. |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Quality by Design Sarwar Beg, Md Saquib Hasnain, 2019-03-27 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 |
| pharmaceutical manufacturing handbook regulations and quality: Good Pharmaceutical Manufacturing Practice John Sharp, 2004-10-15 With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceuti |
| pharmaceutical manufacturing handbook regulations and quality: AHLA Pharmaceutical and Medical Device Compliance Manual (AHLA Members) , 2016 The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.Coverage includes:In-depth coverage of the federal and state enforcement agenciesFederal Anti-Kickback Statute and False Claims Act detailsDistinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label useDiscussion of the Foreign Corrupt Practices Act and its extra-territorial reachCoverage and reimbursement of prescription drugs and medical devicesPrescription drug price regulationsThe Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.EDITORSKathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJSimone Handler-Hutchinson, J.D., Executive Director, SETON HALL LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJCONTRIBUTING AUTHORSBret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ |
| pharmaceutical manufacturing handbook regulations and quality: Good Design Practices for GMP Pharmaceutical Facilities Terry Jacobs, Andrew A. Signore, 2016-08-19 This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices. |
| pharmaceutical manufacturing handbook regulations and quality: EPA Office of Compliance Sector Notebook Project , 1997 |
| pharmaceutical manufacturing handbook regulations and quality: Biocontamination Control for Pharmaceuticals and Healthcare Tim Sandle, 2018-11-30 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 |
| pharmaceutical manufacturing handbook regulations and quality: Pharmaceutical Quality Richard Prince, 2004 |
| pharmaceutical manufacturing handbook regulations and quality: Quality Assurance of Aseptic Preparation Services Alison M. Beaney, 2016 Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries. |
| pharmaceutical manufacturing handbook regulations and quality: Quality Control and Regulatory Aspects for Biologicals Gauri Misra, 2024-04-22 This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives. Key Features: Reviews various scientific and regulatory aspects involved in the quality control of biologicals Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes Explores the use of animal-based testing methods in quality control, as well as their alternatives Discusses guidelines and methodologies involved in the development of biological products Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals. |
| pharmaceutical manufacturing handbook regulations and quality: Kaizen for Pharmaceutical, Medical Device and Biotech Industries Shruti Bhat, 2017-04-05 Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries. For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences. In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques. |
| pharmaceutical manufacturing handbook regulations and quality: Data Retention in Europe and Beyond , 2025-02-18 In the aftermath of the invalidated Data Retention Directive, the Court of Justice of the European Union (CJEU) published extensive case law that shaped the rules, requirements, and safeguards on the retention of traffic and location data and their subsequent access for law enforcement purposes in accordance with EU law. Against this backdrop, Data Retention in Europe and Beyond unites leading scholars and practitioners to offer a cutting-edge and multifaceted analysis of issues relating to data retention. The chapters in this book explore the development of the EU case law, the interaction with European Court of Human Rights (ECtHR) jurisprudence, the interplay between data retention and mass surveillance, the proportionality principle in the CJEU jurisprudence rulings, and data retention in the proposed ePrivacy Regulation. The book offers eleven country-specific analyses of European Member States as well as chapters on the data protection regimes of India, Japan, and the US. Further chapters examine the role of the courts in the context of data retention and discuss epistemic (in)justice. The book also contains extensive contributions on automated analysis of retained data by means of algorithms, and retention as intrinsic facet of administrative and surveillance vulnerability. Comprehensive and informative, this volume not only provides a critical assessment of legal and policy developments, but also will inform policymakers on the potential future for data retention regulation in the European Union and beyond. |
Global pharmaceutical industry - statistics & facts | Statista
Nov 22, 2024 · Consequently, pharmaceutical companies came into the public’s focus, with the pressure to provide results quickly growing. This was especially true for the global leaders of …
Pharmaceutical industry in Germany - statistics & facts
Jan 13, 2025 · The pharmaceutical market is lucrative as medicines are essential to daily life and something that almost everyone will need at some point. Furthermore, it is an industry heavily …
Pharmaceutical industry in Poland - statistics & facts
Apr 25, 2025 · Pharmaceutical spending in Poland has shown a significant upward trend in recent years, reflecting a growing consumer investment in health-related products. In 2023, ...
Pharmaceutical industry in Canada - Statistics & Facts
Feb 9, 2024 · The pharmaceutical industry in Canada is a significant economic segment, employing more than 33 thousand people in the manufacturing sector alone. However, …
Pharmaceutical industry in Italy - Statistics & Facts
Jul 18, 2024 · Industry overview 12 Premium Statistic Pharmaceutical market: worldwide revenue 2001-2024 Basic Statistic Revenue of leading European pharmaceutical markets 2023
Pharmaceutical industry in Argentina - Statistics & Facts
Jan 10, 2024 · The pharmaceutical landscape in Argentina is characterized by a wide variety of over-the-counter (OTC), and prescription drug categories. These include therapeutic …
U.S. pharmaceutical industry - statistics & facts | Statista
Nov 22, 2024 · Top 50 pharmaceutical companies - Rx sales and R&D spending 2023 Leading 50 global pharmaceutical companies by prescription sales and R&D spending in 2023 (in billion …
Pharmaceutical market in Italy - Statistics & Facts | Statista
Premium Statistic Pharmaceutical enterprises in Italy 2023, by capital provenience Market overview Premium Statistic Global pharmaceutical market - revenue distribution 2010-2023, by …
Pharmaceutical industry in Brazil - Statistics & Facts
Feb 12, 2025 · The pharmaceutical industry in Brazil is composed of over 200 companies, of which more than half are located in São Paulo, the most populous city in Brazil. In 2022, ...
Pharmaceutical market in the Philippines - statistics & facts
Dec 21, 2023 · Pharmaceutical products are supplied by multinational companies (MNCs) and local companies. MNCs are marketing and distributing finished medicine products and raw and …
Global pharmaceutical industry - statistics & facts | Statista
Nov 22, 2024 · Consequently, pharmaceutical companies came into the public’s focus, with the pressure to provide results quickly growing. This was especially true for the global leaders of …
Pharmaceutical industry in Germany - statistics & facts
Jan 13, 2025 · The pharmaceutical market is lucrative as medicines are essential to daily life and something that almost everyone will need at some point. Furthermore, it is an industry heavily …
Pharmaceutical industry in Poland - statistics & facts
Apr 25, 2025 · Pharmaceutical spending in Poland has shown a significant upward trend in recent years, reflecting a growing consumer investment in health-related products. In 2023, ...
Pharmaceutical industry in Canada - Statistics & Facts
Feb 9, 2024 · The pharmaceutical industry in Canada is a significant economic segment, employing more than 33 thousand people in the manufacturing sector alone. However, …
Pharmaceutical industry in Italy - Statistics & Facts
Jul 18, 2024 · Industry overview 12 Premium Statistic Pharmaceutical market: worldwide revenue 2001-2024 Basic Statistic Revenue of leading European pharmaceutical markets 2023
Pharmaceutical industry in Argentina - Statistics & Facts
Jan 10, 2024 · The pharmaceutical landscape in Argentina is characterized by a wide variety of over-the-counter (OTC), and prescription drug categories. These include therapeutic …
U.S. pharmaceutical industry - statistics & facts | Statista
Nov 22, 2024 · Top 50 pharmaceutical companies - Rx sales and R&D spending 2023 Leading 50 global pharmaceutical companies by prescription sales and R&D spending in 2023 (in billion …
Pharmaceutical market in Italy - Statistics & Facts | Statista
Premium Statistic Pharmaceutical enterprises in Italy 2023, by capital provenience Market overview Premium Statistic Global pharmaceutical market - revenue distribution 2010-2023, by …
Pharmaceutical industry in Brazil - Statistics & Facts
Feb 12, 2025 · The pharmaceutical industry in Brazil is composed of over 200 companies, of which more than half are located in São Paulo, the most populous city in Brazil. In 2022, ...
Pharmaceutical market in the Philippines - statistics & facts
Dec 21, 2023 · Pharmaceutical products are supplied by multinational companies (MNCs) and local companies. MNCs are marketing and distributing finished medicine products and raw and …
