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  AGENCY WEBSITES

 

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US Food and Drug Administration

 
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FDA Documents

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Electronic Reading Room

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FDA News

 
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Center for Biologics Evaluation and Research (CBER)

 
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CBER Documents

 

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Center for Drug Evaluation and Research (CDER)

 
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CDER Documents

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Division of Manufacturing and Product Quality

 
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Office of Regulatory Affairs

 
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Compliance Documents

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Inspections Documents

 

bullet Code of Federal Regulations:  Food and Drug Administration, Department of Health and Human Services (searchable database)

 

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EudraLex:  The Rules Governing Medicinal Products in the European Union
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Volume 1 - Pharmaceutical Legislation : Medicinal Products for Human Use

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Volume 2 - Pharmaceutical Legislation: Notice to Applicants

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Volume 3 - Medicinal Products for Human Use: Guidelines

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Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice

 
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The European Agency for the Evaluation of Medicinal Products
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Human Medicines

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GMP Home

 
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The European Heads of Agencies

 
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Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S)

 
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National Institutes of Health

 
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Health Canada, Therapeutic Products Programme

 

STANDARDS ORGANIZATIONS

 

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International Conference on Harmonisation

 
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ICH Documents

 

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USP, United States Pharmacopoeia

 
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EP, European Pharmacopoeia

 
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ISO, International Standards Organization

 

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ANSI, American National Standards Institute

 

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ASQ, American Society of Quality

 

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U.S. National Institute of Standards and Technology (NIST)

 

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ASTM, American Society for Testing and Materials

 

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IEEE Standards Association

 

INDUSTRY ASSOCIATIONS

 
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International Society of Pharmaceutical Engineers (ISPE): A global, not-for-profit membership organization that provides education, training, and technical publications to Life Science professionals.  Committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.  Developer of GAMP (Good Automated Manufacturing Practices).

 
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PDA:  Advances pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.  Publishes PDA Letter and PDA Journal.

 
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PharmWeb - PharmWeb Discussion Forum: A PDA sponsored online forum that serves as a platform for exchanging practical, and sometimes theoretical, ideas within the context of some of the most challenging issues confronting the pharmaceutical industry. 

 
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International Confederation of Contamination Control Societies (ICCCS): Coordinates international exchange of contamination control knowledge; coordinates and promotes international contamination control standardization; helps the elimination of technical barriers to trade.

 
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R3Nordic:  Nordic Association for Contamination Control and Clean Rooms (Sweden, Denmark, Norway and Finland).  Interests encompass contamination control and other systems targeted at achieving low levels of contamination and high levels of performance assurance for the protection of personnel and products, and including issues relating to maintenance of systems and operating procedures.  

 
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American Association of Pharmaceutical Scientists:  A professional, scientific society of more than 10,000 members employed in academia, industry, government and other research institutes worldwide. Aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development.

 
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Biotechnology Industry Organization (BIO):  Biotechnology information, advocacy and business support.

 
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Drug Information Association (DIA):  A neutral, global forum, completely independent from the influence of any one organization or authority, in which you can learn about advances, issues, regulations, and trends from the perspective of healthcare companies, academic institutions, and governmental regulatory agencies alike.

 
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International Federation of Pharmaceutical Manufacturers Association (IFPMA):  A non-profit, non-governmental Organization (NGO) representing, through our member associations, the worldwide research-based pharmaceutical industry and manufacturers of prescribed medicines.  Three primary tasks: Develop global position statements on matters of health care policy. Encourage the global exchange of information within our industry. Work closely with international organizations dedicated to health and trade-related issues.

 
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Institute of Validation Technology (IVT):  Dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries through educational publications, timely conferences, and other informational products.

 
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International Pharmaceutical Excipients Council (IPEC):  Works on excipient safety and public health issues, in connection with international trade matters, and to achieve harmonization of regulatory standards and pharmacopoeial monographs.

 
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Pharmaceutical Research and Manufacturers of America (PhRMA): Represents the country's leading research-based pharmaceutical and biotechnology companies.  Conducts advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical/biotechnology research companies.

 
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The Parenteral Society:  Information concerning all aspects of parenteral technology and parenteral administration.  Education and training of personnel in the fields of parenteral technology and administration.

OTHER INDUSTRY LINKS

 
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Key2Compliance:  Compliance seminars and conferences.

 

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RMC Pharmaceutical Solutions Inc.:  RMC Pharmaceutical Solutions (RMCPS), is  ready to help you conquer your challenges during pharmaceutical, biotech and combination (drug/device) product development and commercialization activities. The RMCPS team offers expertise in quality and compliance systems, validation and calibration controls, product/process development and validation, strategic planning, due diligence, and project management. The foundation and scope of this team expertise has been obtained through nearly 60 years of collective experience across start-up, development and commercial-stage organizations.

 
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PharmaNet, Inc.:  Compliance seminars and conferences.

 

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Micro-Virology Laboratories, Inc.Environmental monitoring, microbiology and virology biosafety testing and consulting services.

 

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Biopharm International:  BioPharm provides a peer-reviewed forum for its readers to exchange practical, hands-on information for developing and manufacturing pharmaceutical products through biotechnology; and it provides a supportive, authoritative voice in the evolving business, regulatory, scientific, and technical areas of the biopharmaceutical industry. 

 

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Pharmaceutical Engineering:  Feature articles provide practical application and specification information on the design, construction, supervision, and maintenance of process equipment, plant systems, instrumentation, and facilities.

 

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Pharmaceutical Technology

 

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Cleanroom Technology:  Magazine for the cleanroom industry. 

 

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Journal of Validation Technology

 

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Dickinson's FDA Webview:  Interactive Web site that watches the U.S. Food and Drug Administration all day long. From the leading publisher of FDA-content business newsletters since 1984, you can monitor regulatory, legal, policy and scientific news affecting all FDA-regulated healthcare products and their marketing activities.  Also has links to its print newsletters.

 

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fdainfo.com:  How to find FDA documents and other regulatory news and information.  Links and info for several newsletters and reports.

 

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foi online:  Freedom of Information documents available on-line, anonymously.  

 

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Pharmaceutical Online:  Links to products and suppliers, relevant content and industry news. Serves the needs of pharmaceutical professionals working on pharmaceutical scale-up, pharmaceutical contract manufacturing, pharmaceutical clinical trials, production, processing, manufacturing, engineering, and related regulatory and policy issues. 

 

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FDA News.com:  Exclusive news and analysis on drugs, medical devices and biologics.

 

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The Gold Sheet: Designed for manufacturing and quality control managers concerned with quality control procedures and FDA regulatory and enforcement activities in the pharmaceutical and biological industries. The publication covers developments in FDA regulations and policies governing the manufacture and processing of healthcare products and state-of-the-art production and quality techniques.

 


FDA on Harmonization

Forces Shaping Biological and Biotechnology Products in the 21st Century:

... Global Market: International Harmonization and Competition 

Chris Joneckis, Ph.D., FDA
March 2003


Copyright 2003 Compliance Net, Inc.

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