Good Manufacturing Practice (GMP) Guidelines PDF Download
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Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
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.
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
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.
Author: Ilse Zolle
Publisher: Springer Science & Business Media
ISBN: 3540339906
Category : Medical
Languages : en
Pages : 354
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Book Description
Radioactive drug development is a multi-disciplinary task. Therefore, dedicated scientists and experts from different fields of specialisation have contributed to this book. The text reviews forty years of advances in radiopharmaceutical development based on Technetium. The first section reviews basic principles and analytic methods, and information on chemical makeup of radiopharmaceuticals. Part 2 reviews 99mTc-radiopharmaceuticals used in nuclear medicine, thoroughly outlining their chemistry, formulation, pharmacokinetics and clinical applications.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
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.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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Book Description
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.
Author: International Atomic Energy Agency
Publisher:
ISBN: 9789201173102
Category : Technology & Engineering
Languages : en
Pages : 0
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Book Description
This publication provides practical information for planning and operating a fluorodeoxyglucose (FDG) production facility, including design and implementation of the laboratories, facility layout, equipment, personnel, and quality assessment of FDG. Information useful for assessing the resource requirements, planning and aspects necessary for compliance with the applicable national regulatory requirements for manufacturing of radio-pharmaceuticals is also included.
Author: Elisabeth Eppard
Publisher: BoD – Books on Demand
ISBN: 1839627832
Category : Medical
Languages : en
Pages : 156
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Book Description
In recent years, due to advancing technology and diagnostic and therapeutic techniques, medicine and health care have become more patient-oriented. This concept of personalized medicine or theranostics can be traced back to the beginnings of nuclear medicine when radioisotopes were uncovered as diagnostic and therapeutic tools. Nowadays, the field of theranostics is in flux, as new techniques and materials allow a growing range of applications beneficial for patients. This book examines new developments in theranostics and provides a comprehensive overview of the state of the art in this exciting discipline.
Author: E. Clyde Buchanan
Publisher: ASHP
ISBN: 1585283312
Category : Medical
Languages : en
Pages : 497
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Book Description
Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
Author: F. F. (Russ) Knapp
Publisher: Springer
ISBN: 8132226070
Category : Medical
Languages : en
Pages : 357
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Book Description
This book provides detailed information on therapeutic radiopharmaceuticals and discusses emerging technologies which have potential for broad clinical implementation. Recent advances in molecular biology, radiopharmaceutical chemistry and radioisotope production have stimulated a new era for the use of radiopharmaceuticals for targeted radionuclide therapy (TRT). Emerging clinical trials include use of peptides and monoclonal antibodies radiolabeled with therapeutic radionuclides for cancer therapy. In addition, small molecules are used for the treatment of chronic diseases such as metastatic bone pain palliation and radiation synovectomy of inflammatory joints. In the interventional arena, therapy of primary and metastatic liver cancer and arterial restenosis following angioplasty of both the coronary and peripheral arteries are being explored. Reactor and accelerator production of therapeutic radioisotopes is also integrated into these discussions. The development and use of radiopharmaceutical targeting characteristics required for treatment of specific disease processes and how these are implemented for radiopharmaceutical design strategies are also described. Radiopharmaceuticals for Therapy will benefit audiences in nuclear medicine and radionuclide therapy and will thus prove an invaluable source of up-to-date information for students, radiopharmaceutical scientists and professionals working in the radiopharmacy and nuclear medicine specialties.
Author: Alison M. Beaney
Publisher:
ISBN: 9780857113078
Category : Asepsis and antisepsis
Languages : en
Pages : 0
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Book Description
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.
Author: International Atomic Energy Agency
Publisher:
ISBN: 9789201067081
Category : Nuclear medicine
Languages : en
Pages : 0
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Book Description
Clinically safe, effective and economic practices in the area of hospital radiopharmacy can strengthen the overall performance of nuclear medicine services. This guidance provides practical points at different levels of operation including staff training, facilities, radiopharmaceutical practices, record keeping and quality control. Therefore, it is an essential read for nuclear medicine physicians, radiologists, and radiopharmacists who take responsibility to ensure concordance with internationally recognized practices.
