Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

This book 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. 

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. 

Contents

Acknowledgments

Acronyms and Abbreviations

Summary

Front Matter

Summary

1 Introduction

2 Core Elements of Regulatory Systems

3 Critical Issues

4 A Strategy to Building Food and Medical Product Regulatory Systems

5 International Action

6 Domestic Action

7 Conclusions and Priorities

Appendix A Glossary

Appendix В A Review of Tort Liability's Role in Food and Medical Product Regulation

Appendix С Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China

Appendix D Chinese Food Regulatory System

Appendix E Meeting Agendas

Appendix F Committee Member Biographies

Appendix G Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed

Appendix H Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration

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Handbook of Medical Device Regulatory Affairs in Asia

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. 

A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors.

Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

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Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

• cGMP compliance
• pre-approval inspections
• stability and bioequivalence testing
• packaging commodity development
• common difficulties in formulating drugs
• changes to aNDAs

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Drug Delivery Nanoparticles Formulation and Characterization

Explore the fundamental concepts of drug delivery formulation and characterization.

Nanoparticulate Drug Delivery Systems II presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.

This comprehensive guide features:

100 high quality images Process Analytical Techniques (PAT) used in manufacturing Nanoparticulate Drug Delivery Systems (NDDS) in-vitro and in-vivo evaluation of NDDS applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques.

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Pharmaceutical Suspensions: From Formulation Development to Manufacturing

The suspension dosage form has long been used for poorly soluble active ingredients for various therapeutic indications. Development of stable dispersions over the shelf life of the drug product continues to be a challenge on many fronts.

A good understanding of fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, viscometers, particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require clinical trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with regulatory guidelines. Pharmaceutical Suspensions, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical active dispersed in a suitable vehicle.

After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically detail the development of pharmaceutical suspensions, from pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to pharmaceutical filed is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists skilled in their specific areas. Contributing authors represent a cross-sections of scholars from Academic Institutions, Pharmaceutical Industries and Regulatory Agency.

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Drug-Drug Interactions: Scientific and Regulatory Perspectives, Volume 43 (Advances in Pharmacology)

Drug–Drug Interactions is a comprehensive review of the scientific and regulatory perspectives of drug–drug interactions from the point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry, health care, and governmental regulatory agencies. Topics of interest include the mechanistic understanding of drug–drug interactions, the prediction of drug–drug interaction potential of new drugs, and the avoidance of clinically significant drug–drug interaction in patients.

Key Features

* Provides useful references on the science of drug-drug interactions

* Describes in a basic and comprehensive manner drug-drug interactions from the mechanistic viewpoint

* Contains original data from academic and industrial laboratories

* Presents an overview of regulatory agency positions

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Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

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Air Quality, 4th Edition

Ozone-destroying chemicals, greenhouse gases, and dangerous airborne substances that were once thought to be benign are the most urgent issues facing air pollution control experts. Students need a thorough, updated reference that explores these current trends while also covering the fundamental concepts of this emerging discipline. A new revision of a bestseller, Air Quality, Fourth Edition provides a comprehensive overview air quality issues, including a better understanding of atmospheric chemistry, the effects of pollution on public health and the environment, and the technology and regulatory practices used to achieve air quality goals. New sections cover toxicological principles and risk assessment. The book also contains revised discussions on public policy concerns, with a focus on air quality standards for ozone depletion and global warming, and the health effects of particulate air pollutants. This edition continues to serve as a very readable text for advanced level undergraduate and early graduate study in environmental science, environmental management, and in programs related to the study of public health, industrial hygiene, and pollution control.

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New Drug Approval Process: The Global Challenge

"This text [is] a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." -- Journal of Medicinal Chemistry

"…very valuable…

"…should be a required reading….highly recommended." -- Guarino

"…very valuable… "…should be a required reading for anyone entering the strait-jacket world of modern pharmaceutical development….highly recommended. -- Pharmaceutical Development and Technology

Oxford Pharmaceutical Resources, Inc., Totowa, NJ. Covers the new emphasis on over-the-counter drugs, latest techniques of institutional review boards, Good Clinical Practice standards set by the FDA, adverse drug reaction standards, and more. For professionals in pharmaceutical industry.

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Filtration in the Biopharmaceutical Industry

This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines)

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest.

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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis)

Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.

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Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.

This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.

It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.

- Provides valuable information on isolation and characterization of impurities.
- Gives a regulatory perspective on the subject.
- Describes various considerations involved in meeting regulatory requirements.
- Discusses various sources of impurities and degredation products.

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Guidelines for Failure Modes and Effects Analysis for Medical Devices

Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis. Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

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International Pharmaceutical Product Registration

This reference text for the pharmaceutical industry sets out the regulatory requirements of the authorities of the major world market. The editors identify major key technical and scientific areas in any application for marketing authorization.

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International Research in Healthcare

This book is an essential guide for those thinking of undertaking a multi-centre research project. Research across international boundaries presents challenges with the need to consider relevance of research objectives and feasibility of procedures in different settings whilst maintaining scientific integrity in terms of design, instruments and execution.

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Protein Formulation and Delivery

This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability! Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery · includes a discussion of accelerated stability testing and its limitations in identifying stable formulations · details analytical methods commonly used in stability assessment and formulation development · stresses the importance of demonstrating the stability-indicating nature of an assay · describes the drug substance manufacturing process succinctly · examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration · covers aseptic processing in drug development and the potential development of a freeze-drying cycle · explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms · discusses the physical and chemical characteristics of proteins in microsphere delivery systems · analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation · explores formulations intended for injection, inhalation, and controlled delivery · and more! Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.

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A Pharmacology Primer, Third Edition: Theory, Application and Methods

This successful guide assists scientists trained in molecular biology and related fields who now need to know the basic theories, principles and practical applications of pharmacology. This latest edition continues the tradition of better preparing researchers in the basics of pharmacology. With expanded hands-on exercises and the addition of Pharmacokinetics coverage, new human interest material including historical facts in pharmacology and a new section on therapeutics that will help readers identify with diseases and drug treatments.

The ideal book for researchers in drug discovery who have seen their role shift from "individual" to "team player" where that team includes chemists, biologists, and others with strong, but varied, science backgrounds who must now work together toward their common pharmacology goal.

At GlaxoSmithKline, a pharmaceuticals world-leader, Terry Kenakin regularly teaches a course for their research scientists and has drawn on his experience to create a pharmacology primer.

*New - Latest coverage of the chemistry of drugs including expanded coverage of the pharmacokinetic discussion of druglike properties -- Increases reader understanding of necessary ADME (Absorption, Distribution, Metabolism, and Excretion) properties and increases the rate of drug approval and acceptance.

*Context - Unique discussions on various drug discovery teams and the role of the chemist on those teams -- Promotes the understanding of these expanding roles and responsibilities and how to maximize the effective contributions of each matrix team member.

*Real-world learning - There are hands-on exercises, with extensive answers, utilizing real data on structure activity relationships; utilization of pharmacological principles to make general statements about how changes in structure lead to changes in drug activity. + hands on exercises with extensive answers on Pharmacokinetics -- Stengthens practical application and understanding of core concepts and principles.

*Study sections are organized with ASPET (American Society for Pharmacology and Experimental Therapeutics)and other international organizations -- Ensures that learning follows professional industry standards.

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Global Regulatory Issues for the Cosmetics Industry: Volume 1

The manufacture and use of cosmetics is an international undertaking unparalleled by any other industry. Regulation of this industry, however, is neither universal nor consistent. The purpose of this book (the first of a series) is to simplify the complex global Cosmetic Regulatory landscape by addressing the issues affecting the manufacture, packaging, and marketing of cosmetic products across the globe. Included are several chapters that examine the new European Union REACH regulation (Registration Evaluation and Authorization of CHemicals). Other chapters look at regulatory developments of individual countries, toxicity requirements, as well as how to develop a global regulatory strategy.

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