Download or read book Risk based Management of GMP Audits written by Viola Hieble-Gerhard and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Download or read book Quality Risk Management in the FDA Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Download or read book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing written by Hamid Mollah and published by John Wiley & Sons. This book was released on 2013-03-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Gmp Audit Trainer written by Brendan Cooper, Mr. and published by . This book was released on 2017-07-07 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Both internal and external GMP audits/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included:Introduction to Good Manufacturing Preparation for AuditsInspection of Quality Systems During the InspectionBiotechnology Inspection GuideMedical Device Inspection GuideDrugs Inspection Guide Computerised Systems Inspection GuideCHAPTER 8Computerised Systems Inspection GuideIntroduction 94Hardware 94Validation of Hardware 96Software 98Electronic Records and Signatures 106Electronic Records Verification Methods 117
Download or read book GMP Audits in Pharmaceutical and Biotechnology Industries written by Mustafa Edik and published by CRC Press. This book was released on 2024-06-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Download or read book Risk Management in the Pharmaceutical Industry written by and published by . This book was released on 2008 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 21st Century Quality Management and Good Management Practices written by S Williams and published by Elsevier. This book was released on 2025-04-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The life sciences industry is changing rapidly and the historical rules, regulations, government oversight are under pressure to modernize. The recent introduction of Pharmaceutical Quality Systems (PQS), Pharmaceutical Risk Management (QRM), Quality by Design (QbD), Process Analytical Technology (PAT) and risk-based validation have all challenged the traditional view that simple compliance with the basic Good Management Practices (GMP) rules is enough to satisfy stakeholders, regulators and patients. This book draws together these leading edge concepts and technologies and explains how they interlink with the traditional GMP rules and quality assurance. The book is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance. The book serves as a practitioners guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance. Addresses the practical application of quality management and GMPs Draws together five 21st century industry initiatives that will shape the future of industry compliance Moves readers from thinking about 'rule-based' compliance to 'value added' compliance
Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Download or read book The Certified Pharmaceutical GMP Professional Handbook Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Download or read book Food Safety and Protection written by V Ravishankar Rai and published by CRC Press. This book was released on 2017-09-18 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of issues associated primarily with food safety, shelf-life assessment and preservation of foods. Food safety and protection is a multidisciplinary topic that focuses on the safety, quality, and security aspects of food. Food safety issues involve microbial risks in food products, foodborne infections, and intoxications and food allergenicity. Food protection deals with trends and risks associated with food packaging, advanced food packaging systems for enhancing product safety, the development and application of predictive models for food microbiology, food fraud prevention, and food laws and regulations with the aim to provide safe foods for consumers. Food Safety and Protection covers various aspects of food safety, security, and protection. It discusses the challenges involved in the prevention and control of foodborne illnesses due to microbial spoilage, contamination, and toxins. It starts with documentation on the microbiological and chemical hazards, including allergens, and extends to the advancements in food preservation and food packaging. The book covers new and safe food intervention techniques, predictive food microbiology, and modeling approaches. It reviews the legal framework, regulatory agencies, and laws and regulations for food protection. The book has five sections dealing with the topics of predictive microbiology for safe foods; food allergens, contaminants, and toxins; preservation of foods; food packaging; and food safety laws.
Download or read book The ASQ Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2024-09-30 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
Download or read book GAMP Good Practice Guide written by and published by . This book was released on 2010 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth volume in the series covers the techniques and technologies involved in the preparation of semisolid products such as ointments, creams, gels, suppositories, and special topical dosage forms. Drug manufacturers need a thorough understanding of the specific requirements that regulatory agencies impose on the formulation and efficacy deter
Download or read book Preparing for FDA Pre Approval Inspections written by Martin D. Hynes and published by CRC Press. This book was released on 2016-04-19 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
