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HULL
an SP Industries brand

935 Mearns Road
Warminster, PA 18974

800-523-2327 : tel
215-672-7800 : tel
215-672-7807 : fax


SP Industries' Pharmaceutical and BioTech Industry Links

Unlike a lyophilized product, the Web is a very fluid environment. If you find a broken link or have a site you would like to see added, please contact us

Use our browser links page if you wish to upgrade or replace your browser. This page also provides a link to the free Adobe Acrobat® PDF Reader.


21 CFR Part 11, Electronic Records and Signatures

21CFR Part11 A site devoted to 21CFR Part 11 with a great deal of useful information as well as links to other resources.

While we do not normally endorse commercial sites, we felt this was of such great interest to our industry and so well done we had to include it in our links. Hull, VirTis, FTS, and Hotpack control systems support this standard.

ORA The FDA Electronic Records and Electronic Signatures Reference

21 CFR Parts 210 and 211, Asceptic Processing

210-211 The Center for Drug Evaluation and Research page with links to The Current Codified CGMP Regulations 21 CFR, Parts 210 and 211.

FDA - Current Good Manufacturing Processes

cGMP "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach"

Also refer to The News Release and The Questions and Answers regarding these new FDA guidelines.

cGMP "Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach- Final Report - Fall 2004"
cGMP "Sterile Drug Products produced by Aseptic Processing - Current Good Manufacturing Practice":
cGMP Current Good Manufacturing Practices for Asceptic Drug Production -Documents Index
PAT "Process Analytical Technology (PAT) Initiative"

Also refer to The FDA PAT Literature page.


Professional Organizations

AAAS American Association for the Advancement of Science
AACC American Association for Clinical Chemistry
AAMI Association for the Advancement of Medical Instrumentation
APS The American Physiological Society
AAPS American Association of Pharmaceutical Scientists

(AAPS Alternate Site Address)

ABSA American Biological Safety Association
ACS American Chemical Society

Also see the ACS Scientists site.

AFSS American Filtration and Seperations Society
AIChE American Institute of Chemical Engineers
AOAC AOAC International -Association of Official Analytical Chemists
ANSI American National Standards Institute
ASGT American Society of Gene Therapy
ASHRAE The American Society of Refrigeration and Airconditioning Engineers
ASM American Society for Microbiology
ASME American Society of Mechanical Engineers
ASQ American Society for Quality
ASTM American Society for Testing and Materials
AVS AVS The Science and Technology Society (formerly The American Vacuum Society)
BIO Biotechnology Industry Organization
CLAS Clinical Ligand Assay Society
CRS Controlled Release Society
CASSS California Seperation Science Society
DIA Drug Information Association.
NOTE: This site demands you enable Java and allow it to plant "cookies" before it will allow you to enter.
ES The Electrophoresis Society
EUFEPS European Federation for Pharmaceutical Sciences
ESACT European Society for Animal Cell Technology
FASEB Federation of American Societies for Experimental Biology
TIGR The Institute for Genomic Research
IAPBA International Association for Pharmaceutical and Biomedical Analysis
IATDMCT International Association of Therapeutic Drug Monitoring and Clinical Toxicology
ICH International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human Use
IPEC International Pharmaceutical Excipients Council
ISO.1 ISO Information on Conferences and Standards
ISO.2 ISO9000:2000 The New ISO Standard for Quality Managment
ISO.3 The Home Page for the International Organization for Standardization
ISO.4 The Home Page for the ISO Technical Committee
ISPE International Society of Pharmaceutical Engineers

ISPE Delaware Valley Chapter

ISPE Great Lakes Chapter

ISPE Rocky Mountain Chapter

ISPE San Francisco Chapter

IUPHAR International Union of Pharmacology
NAPM The National Association of Pharmaceutical Manufacturers
National
Academies
The National Academies of Sciences, Engineering, Medicine, and the National Research Council
NIDI The Nickel Development Institute (Stainless Steel Engineering Resources)
PDA The Parenteral Drug Association
PDE The Pharmaceutical Trade Association
Parenteral The Parenteral Society (UK)
POMA Pharmaceutical Outsourcing Management Association
PhrMA Pharmaceutical Research and Manufacturers of America
PSC Pharmaceutical Society of Canada
PPS01 Photostability of Drugs Interest Group
PQRI Product Quality Research Institute
RAPS Regulatory Affairs Professionals Society
SBS Society for Biomolecular Screening
SIM Society for Industrial Microbiology
SIV Society for In Vitro Biology
SME Society of Manufacturing Engineers
USP The United States Pharmacopeia Convention, Inc.
WBF The World Batch Forum

Government Agencies and Institutional Research

CBER Center for Biologics Evaluation and Review
CDC The Center for Disease Control
CDER The Center for Drug Evaluation and Review

CDER_OB The CDER Electronic Orange Book

CDER_DA The CDER Drug Approval Listing

CDER_HB The CDER Handbook

CDER_RG The CDER Regulatory Guidance Links Page

CDER_DM The CDER Data Standards Manual

CDER_PP The CDER Manual of Policies and Procedures

Census The United States Census
CFR The Code of Federal Regulations
CPPR The Center for Pharmaceutical Processing Research
EPA The United States Envirionmental Protection Agency
FDA United States Food and Drug Administration
FDA Forms Downloadable FDA Forms
FedWorld The Federal Gateway to over 100+ Government Sponsored Sites
FirstGov The Federal Portal to All Government Sites
FTC The Federal Trade Commission
LOC The United States Library of Congress
NCBI National Center for Biotechnology Information
SIBS Salk Institute for Biological Studies
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.
WIBR Whitehead Institute for Biomedical Research

Industry Magazines and Journals

Innocentive A site which lists Pharmaceutical, BioTech, and Chemical challenges to be solved. You can post your problem or submit your solution.
Bio-IT World Bio-IT World Magazine
Cleanrooms Cleanrooms Magazine
Note: A very complex and intrusive website with many cookies. Not recommended for dial-up modems or older browsers.
Drug Discovery Drug Discovery and Development Magazine
Drug Topics Drug Topics newsletter for Pharmacists
Euro Journal The European Journal of Parenteral Sciences
Euro Review The European Pharmaceutical Review
Genomics The Genomics & Proteomics Magazine website.
Pharm Cast A Pharmaceutical Industry oriented website with good Regulatory News and Links
Pharm Mfg Pharmaceutical Manufacturing Magazine

Green Resources Library for Energy Efficiency Improvements within the Pharmaceutical Industry: Green Library

Pharm Online The PharmaceuticalOnline Website
Pharm Port Advanstar Communications Group Pharmaceutical Website
Pharm Proc Pharmaceutical Processing Magazine
Pharm Qual Pharmaceutical Formulation & Quality Magazine
Pharm Tech Pharmaceutical Technology Magazine
Powder Mag Powder and Bulk Solids Magazine
R & D Magazine Research and Development Magazine
Small Times Small Times Magazine -devoted to Nanotechnology, Micro Electro Mechanical devices, and everything small.

Miscellany

W3C The World Wide Web Consortium
IANA Internet Assigned Names Authority
Usability The US Government's Website Usability Guidelines
RFC The Internet Engineering Task Force's Request For Comments

A useful alternative site is FAQS.org/rfcs/


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