Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Guides to Pollution Prevention written by and published by . This book was released on 1991 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks

Download or read book Good Manufacturing Practice GMP Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 Patient Assessment in Clinical Pharmacy written by Sherif Hanafy Mahmoud and published by Springer. This book was released on 2019-03-28 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, first-of-its kind title is an indispensable resource for pharmacists looking to learn or improve crucial patient assessment skills relevant to all pharmacy practice settings. Pharmacists’ role as health care practitioners is evolving as they are taking a more active part in primary patient care -- helping patients manage their medications and diseases, providing patient education, and, in some jurisdictions, prescribing and adapting medications. To perform their day-to-day duties, pharmacists are best-served using a framework called the patient care process. This framework involves three steps: patient assessment; care plan development and implementation; and monitoring and follow up. Organized in four parts, this practical book begins with introductory chapters regarding the basics of patient assessment and the patient care process. Part II includes a detailed assessment of common symptoms encountered by pharmacists. Part III discusses assessment of patients with various chronic illnesses. Part IV addresses select specialized topics and assessment considerations. An invaluable contribution to the literature, Patient Assessment in Clinical Pharmacy: A Comprehensive Guide will be of great benefit to pharmacists, regardless of their practice setting, and to pharmacy students as well.

Download or read book Handbook of Pharmaceutical Manufacturing Formulations Third Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-12-06 with total page 593 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Download or read book The Fisherman s Guide To Selling written by Joe DiMisa and published by Simon and Schuster. This book was released on 2007-02-12 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cast the right bait, and reel in the sales! Sales expert Joseph DiMisa draws on his experience as a seasoned saltwater fisherman to explain how to land the big one, or sale, through the eyes of an angler. In The Fisherman's Guide to Selling, DiMisa explains strategies used for catching everything from small fish (frequent transactional sales) to big game fish (a GBP 100k+ account). Handy sales tips, useful checklists and a bounty of clever fishing metaphors complement the content to describe a successful sales process that any salesperson will benefit from: knowing what the fish (clients) are biting keeping the tackle box full casting a wide net and checking the lines and preparing for rough seas ahead

Download or read book Manual for Pharmacy Technicians written by Bonnie S. Bachenheimer and published by ASHP. This book was released on 2010-09-10 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: The trusted training resource for pharmacy technicians at all levels. The role of pharmacy technicians is rapidly expanding, and demand for well-trained technicians has never been higher! Technicians are assuming more responsibilities and are taking on greater leadership roles. Quality training material is increasingly important for new technicians entering the field, and current technicians looking to advance. Look no further than the new 4th edition of the best-selling Manual for Pharmacy Technicians to master the practical skills and gain the foundational knowledge all technicians need to be successful. NEW chapters cover the latest essentials: Specialty Pharmacy Practice Communication and Teamwork Billing and Reimbursement Durable and Nondurable Medical Equipment, Devices, and Supplies NEW features include: Full color design, photos and illustrations enhance learning Rx for Success boxes share tips to help techs excel on the job Technology Topics highlight the latest in automation & technical areas Safety First features provide critical advice for enhancing safety & reducing errors Bolded key terms defined in chapter-level glossaries Streamlined contents divide book into 4 simple parts: introduction to pharmacy practice, foundation knowledge and skills, practice basics, and business applications Expanded self-assessment questions and calculations content Alone or with the new edition of the Pharmacy Technician Certification Review and Practice Exam, the Manual for Pharmacy Technicians, 4th Edition offers pharmacy technicians the most relevant, authoritative, easy-to-use guide in the field. Want more exercises and practice? Look for the NEW Workbook for the Manual for Pharmacy Technicians.

Download or read book Index of NLM Serial Titles written by National Library of Medicine (U.S.) and published by . This book was released on 1984 with total page 1584 pages. Available in PDF, EPUB and Kindle. Book excerpt: A keyword listing of serial titles currently received by the National Library of Medicine.

Download or read book Modern Aspects of Pharmaceutical Quality Assurance written by Minal Ghante and published by Springer Nature. This book was released on with total page 525 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

Download or read book Complete Healthcare Compliance Manual 2021 written by and published by . This book was released on 2021-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Bibliographic Guide to North American Industry written by Dale A. Stirling and published by Scarecrow Press. This book was released on 2009-03-26 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: With a view toward the heritage of North American Industry, A Bibliographic Guide to North American Industry: History, Health, and Hazardous Waste provides recommended readings in historical and contemporary literature related to the origins of specific industries, the health and safety issues they face, and how they manage waste and prevent pollution. It encompasses three areas of industry that are critical to understanding the whole of industry: historical development, protection of worker health, and management of associated hazardous substances and materials. This publication serves the reference needs of researchers examining issues of historical development of industry, worker exposure to hazardous substances and materials, and historic and contemporary management of hazardous wastes. The book is unique in using the North American Industrial Classification System as a framework for organizing bibliographic entries. Attorneys, historians, economists, and all others interested in historical and contemporary issues facing North American industry find here a useful and important resource.

Download or read book Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy written by Mahmoud Aljurf and published by Springer Nature. This book was released on 2021-02-19 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.