Pharmaceutical and BioTechnology Industry and Regulatory Links
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21 CFR Part 11 - Electronic Records and Signatures
21 CFR Part 11 A site devoted to 21 CFR Part 11 with links to additional resources. Hull control systems support this standard.
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
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 Seperations 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 Airconditioning 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 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 Nickel Development Institute Stainless Steel Engineering Resources
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
Government Agencies
Center for Biologics Evaluation and Review
The Center for Disease Control
The United States Census
The Code of Federal Regulations
The United States Department of Agriculture
The United States Envirionmental Protection Agency
The United States Food and Drug Administration
FDA Regulatory Information
FDA Inspection and Compliance Information
FDA Online Forms for Downloading
The United States Federal Gateway 100+ Government Sponsored Sites
The United States Federal Portal to All Government Sites
The United States Federal Trade Commission
The United States Library of Congress
The United States Patent and Trademark Office
The World Intellectual Property Organization- an agency of the United Nations.
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
Industry Magazines and Journals
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 Manufacturing Magazine
Pharmaceutical Manufacturing Magazine - Green Library Energy Efficiency Improvements within the Pharmaceutical Industry:
The PharmaceuticalOnline Website
Pharmaceutical Processing Magazine
Pharmaceutical Formulation & Quality Magazine
Pharmaceutical Technology Magazine
Powder and Bulk Solids Magazine
Research and Development Magazine
World Wide Web 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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