Sources Of Contamination In Medicinal Products And Medical Devices

Author : Denise Bohrer
Publisher : John Wiley & Sons
Page : 592 pages
File Size : 44,8 Mb
Release : 2012-09-25
Category : Science
ISBN : 9781118449059

Get Book

Sources of Contamination in Medicinal Products and Medical Devices by Denise Bohrer Pdf

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.

Author : Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Page : 274 pages
File Size : 47,8 Mb
Release : 2000-08-17
Category : Medical
ISBN : 9780203305195

Get Book

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices by Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer Pdf

Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi

Author : National Research Council,Institute of Medicine,Food and Nutrition Board,Board on Agriculture,Committee on Drug Use in Food Animals,Panel on Animal Health, Food Safety, and Public Health
Publisher : National Academies Press
Page : 276 pages
File Size : 45,6 Mb
Release : 1999-01-12
Category : Medical
ISBN : 9780309175777

Get Book

The Use of Drugs in Food Animals by National Research Council,Institute of Medicine,Food and Nutrition Board,Board on Agriculture,Committee on Drug Use in Food Animals,Panel on Animal Health, Food Safety, and Public Health Pdf

The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publisher : National Academies Press
Page : 366 pages
File Size : 55,8 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

Get Book

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Pdf

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.

Author : Tim Sandle
Publisher : Elsevier
Page : 510 pages
File Size : 54,7 Mb
Release : 2024-02-09
Category : Medical
ISBN : 9780443216015

Get Book

Biocontamination Control for Pharmaceuticals and Healthcare by Tim Sandle Pdf

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

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 42,6 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

Get Book

Medical Devices by World Health Organization Pdf

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

Author : Luis Jimenez
Publisher : CRC Press
Page : 328 pages
File Size : 49,7 Mb
Release : 2019-10-17
Category : Electronic
ISBN : 0367393948

Get Book

Microbial Contamination Control in the Pharmaceutical Industry by Luis Jimenez Pdf

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.

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 40,9 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

Get Book

Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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.

Author : World Intellectual Property Organization
Publisher : WIPO
Page : 259 pages
File Size : 41,5 Mb
Release : 2013
Category : Law
ISBN : 9789280523089

Get Book

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by World Intellectual Property Organization Pdf

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Author : Anonim
Publisher : Unknown
Page : 32 pages
File Size : 54,9 Mb
Release : 1995
Category : Food adulteration and inspection
ISBN : MINN:31951D01277485E

Get Book

The Food Defect Action Levels by Anonim Pdf

Author : United States Food and Drug Administration
Publisher : Createspace Independent Publishing Platform
Page : 92 pages
File Size : 41,8 Mb
Release : 2017-09-21
Category : Electronic
ISBN : 1976578671

Get Book

Pharmaceutical Microbiology Manual by United States Food and Drug Administration Pdf

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Author : Sina Ebnesajjad
Publisher : Elsevier Inc. Chapters
Page : 368 pages
File Size : 40,8 Mb
Release : 2013-12-05
Category : Technology & Engineering
ISBN : 9780128076682

Get Book

Handbook of Polymer Applications in Medicine and Medical Devices by Sina Ebnesajjad Pdf

This chapter focuses on adhesives used in direct physiological contact in dental and medical procedures. Activity in both areas has been quite extensive outside the United States for decades. In contrast, adhesive use in medical devices, patches, and plasters has been ongoing in the United States for a long time. In the case of medical devices, adhesion is concerned with the joining of materials such as plastics, elastomers, textiles, metals, and ceramics, which are examined in other chapters of the present volume and are covered in various references [1–6], The coverage of this chapter is devoted to applications where to adhesives are in direct contact with tissues and other live organs.

Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 51,8 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073

Get Book

Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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

Author : Organisation for Economic Co-Operation and Development (OECD)
Publisher : IWA Publishing
Page : 138 pages
File Size : 52,9 Mb
Release : 2020-07-15
Category : Science
ISBN : 9781789061819

Get Book

Pharmaceutical Residues in Freshwater: Hazards and Policy Responses by Organisation for Economic Co-Operation and Development (OECD) Pdf

This report calls for a better understanding of the effects of pharmaceutical residues in the environment, greater international collaboration and accountability distribution, and policy actions to prevent and remedy emerging concerns. Laboratory and field tests show traces of oral contraceptives causing the feminisation of fish and amphibians, and residues of psychiatric drugs altering fish behaviour. Antimicrobial resistance, linked to the overuse of antibiotics, has rapidly escalated into a global health crisis. Unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide. The report outlines a collective, life‑cycle approach to managing pharmaceuticals in the environment. A policy mix of source‑directed, use‑orientated and end‑of‑pipe measures, involving several policy sectors, can help to improve health and protect the environment.

Author : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 511 pages
File Size : 53,6 Mb
Release : 2019-12-02
Category : Technology & Engineering
ISBN : 9781119356127

Get Book

Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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