Industry Links

Pharmaceutical and Biotechnology Industry and Regulatory Links

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21 CFR Part 11 - Electronic Records and Signatures

 

21 CFR Part 11Hull control systems support the 21 CFR Part 11 specification.


21 CFR Parts 210 and 211 - Asceptic Processing
Current Good Manufacturing Practices

 

The Center for Drug Evaluation and Research - Division of Manufacturing and Product Quality

FDA Drug Development and Approval Manufacturing page -guidance documents and references

FDA Guidance, Compliance, and Regulatory Information - cGMP Questions and Answers


Government Agencies

 

CBER - Center for Biologics Evaluation and Review

CDC - The Center for Disease Control

CFR - The Code of Federal Regulations

EPA - The United States Envirionmental Protection Agency

FDA - The United States Food and Drug Administration

FDA - Regulatory Information

FDA - Inspection and Compliance Information

FDA - Online Forms for Downloading

FTC - The United States Federal Trade Commission

ICH - International Conference on Harmonisation

LOC - The United States Library of Congress

USDA - The United States Department of Agriculture

USPTO - The United States Patent and Trademark Office

WIPO - The World Intellectual Property Organization- an agency of the United Nations.

The United States Federal Gateway 100+ Government Sponsored Sites

The United States Portal to All Government Sites


Institutional Research

 

The Center for Pharmaceutical Processing Research

J. Craig Venter Institute - Genomic Research

Innocentive A site which lists Pharmaceutical, BioTech, and Chemical challenges to be solved. You can post your problem or submit your solution.

National Center for Biotechnology Information - Resource Guide NCBI was established in 1988 as a national resource for molecular biology information, The website offers well organized information, software tools, and public databases.

The National Institute for Pharmaceutical Technology and Education

Salk Institute for Biological Studies

Whitehead Institute for Biomedical Research


Professional Organizations

 

American Association for the Advancement of Science

American Association for Clinical Chemistry

Association for the Advancement of Medical Instrumentation

The American Physiological Society

American Association of Pharmaceutical Scientists

American Association of Pharmaceutical Scientists - API The Active Pharmaceutical Ingredient (API) Manufacturing Technology Focus Group.

American Biological Safety Association

American Chemical Society

American Filtration and Separations Society

American Institute of Chemical Engineers

Association of Official Analytical Chemists - International

American National Standards Institute

The Academy of Pharmaceutical Sciences

American Society of Gene Therapy

The American Society of Refrigeration and Air-Conditioning Engineers

American Society for Microbiology

American Society of Mechanical Engineers

American Society for Quality

American Society for Testing and Materials

AVS - The Science and Technology Society Formerly The American Vacuum Society

Biotechnology Industry Organization

An International Separation Science Society

Controlled Release Society

Canadian Society for Pharmaceutical Sciences

Drug Information Association Note: This site requires you enable Java and "cookies" to enter.

The Electrophoresis Society

European Federation for Pharmaceutical Sciences

European Society for Animal Cell Technology

Federation of American Societies for Experimental Biology

International Association of Therapeutic Drug Monitoring and Clinical Toxicology

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

International Federation of Pharmaceutical Manufacturers & Associations

Institute of Environmental Sciences and Technology (IEST) an internationl group centered on Contamination Control, Test and Reliability, and Nanotechnology

International Pharmaceutical Excipients Council - Americas

International Pharmaceutical Excipients Council - China

International Pharmaceutical Excipients Council - Europe

International Pharmaceutical Excipients Council - Japan

ISO - International Organization for Standardization

ISO - Information on Conferences and Standards

International Society of Pharmaceutical Engineers

International Society of Pharmaceutical Engineers - Delaware Valley Chapter

The National Academies of Sciences, Engineering, Medicine, and the National Research Council

The National Institute for Health and Clinical Excellence (UK)

The Parenteral Drug Association

The Pharmaceutical Trade Association

The Pharmaceutical and Healthcare Sciences Society

Pharmaceutical Research and Manufacturers of America

Product Quality Research Institute

Regulatory Affairs Professionals Society

Society for Biomolecular Screening

Society for Industrial Microbiology

Society for In Vitro Biology

Society of Manufacturing Engineers

The United States Pharmacopeia Convention, Inc.

WBF - The Organization for Production Technology


Industry Magazines, Journals, and Blogs

 

AAPS Pharma Gateway AAPS Portal to various journals, presentations, research articles, and themed materials specific to AAPS-sponsored activities.

American Pharmaceutical Review Magazine

Bio-IT World Magazine

Controlled Environments Magazine

Drug Discovery and Development Magazine

Drug Topics newsletter for Pharmacists

The European Journal of Parenteral Sciences

The European Pharmaceutical Review

Pharm Cast A Pharmaceutical Industry oriented website with Regulatory News and Links.

Pharmaceutical Formulation & Quality Magazine

Pharmaceutical Manufacturing Magazine

Pharmaceutical Manufacturing Magazine - Green Library Energy Efficiency Improvements within the Pharmaceutical Industry:

The PharmaceuticalOnline Website

Pharmaceutical Processing Magazine

Pharma QbD Website Pharmaceutical Quality by Design

Pharmaceutical Technology Magazine

Powder and Bulk Solids Magazine

Research and Development Magazine


Internet Resources

 

The World Wide Web Consortium W3C is an international community whose members, staff, and the public develop Web standards.

The Internet Assigned Names Authority IANA is responsible for the global coordination of the DNS Root, IP addressing, and other Internet protocol resources.

The Internet Corporation for Assigned Names and Numbers ICANN is responsible for the assignment and coordination of the Domain Names system and allocation of Internet Protocal addresses.

The United State Government Website Usability Guidelines

The Internet Engineering Task Force's Request For Comments (RFCs) "The mission of the IETF is to make the Internet work better by producing high quality, relevant technical documents that influence the way people design, use, and manage the Internet."

FAQS.org/rfcs/ A RFC archive site.

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