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
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
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
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
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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