Sources Of Contamination In Medicinal Products And Medical Devices
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Sources Of Contamination In Medicinal Products And Medical Devices
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Author : Denise Bohrer
language : en
Publisher: John Wiley & Sons
Release Date : 2012-09-25
Sources Of Contamination In Medicinal Products And Medical Devices written by Denise Bohrer and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-25 with Science categories.
The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.
Report On The Prevention Of Microbial Contamination Of Medicinal Products
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Author : Great Britain. Medicines Commission
language : en
Publisher:
Release Date : 1973
Report On The Prevention Of Microbial Contamination Of Medicinal Products written by Great Britain. Medicines Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1973 with Medical categories.
Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-09-03
Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-03 with Medical categories.
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Biocontamination Control For Pharmaceuticals And Healthcare
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Author : Tim Sandle
language : en
Publisher: Elsevier
Release Date : 2024-02-09
Biocontamination Control For Pharmaceuticals And Healthcare written by Tim Sandle and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-09 with Medical categories.
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy
Microbial Contamination Control In The Pharmaceutical Industry
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Author : Luis Jimenez
language : en
Publisher: CRC Press
Release Date : 2019-10-17
Microbial Contamination Control In The Pharmaceutical Industry written by Luis Jimenez and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-17 with categories.
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Medical Devices
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2010
Medical Devices written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Medical categories.
Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
The Food Defect Action Levels
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Author :
language : en
Publisher:
Release Date : 1995
The Food Defect Action Levels written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Food adulteration and inspection categories.
Pharmaceuticals And Personal Care Products Waste Management And Treatment Technology
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Author : Majeti Narasimha Vara Prasad
language : en
Publisher: Butterworth-Heinemann
Release Date : 2019-04-04
Pharmaceuticals And Personal Care Products Waste Management And Treatment Technology written by Majeti Narasimha Vara Prasad and has been published by Butterworth-Heinemann this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-04 with Science categories.
Pharmaceuticals and Personal Care Products Waste Management and Treatment Technology: Emerging Contaminants and Micro Pollutants provides the tools and techniques for identifying these contaminates and applying the most effective technology for their remediation, recovery and treatment. The consumption of pharmaceuticals and personal care products (PPCPs) has grown significantly over the last 35 years, thus increasing their potential risk to the environment. As PPCPs are very difficult to detect and remove using conventional wastewater treatment methods, this book provides solutions to a growing problem. Includes sampling, analytical and characterization methods and technology for detecting PPCPs in the environment Provides advanced treatment and disposal technologies for the removal of PPCPs from wastewater, surface water, landfills and septic systems Examines the pathways of PPCPs into the environment
Countering The Problem Of Falsified And Substandard Drugs
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-06-20
Countering The Problem Of Falsified And Substandard Drugs written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-20 with Medical categories.
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.