Client Resources
- Global Standards and Guidelines
- Professional and Industry Organizations
- U.S. Government Agencies
- News Sources
- Baltimore Bioscience Community
Global Standards and Guidelines
- GMP Regulations/Guidelines - International
- Standards and Regulations from 21CFRPart11.com
- European Medicines Agency
- SAIGlobal.com (a comprehensive site to purchase some standards)
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme- jointly referred to as PIC/S
- Medicines and Healthcare products Regulatory Agency (MHRA): (UK MCA)
- European Committee For Standardization (CEN)
- International Conference on Harmonisation (ICH)
- International Organization for Standardization (ISO)
- USP 797
Professional and Industry Organizations
- PDA: An International Association for Pharmaceutical Science and Technology
- International Society for Pharmaceutical Engineering (ISPE)
- Regulatory Affairs Professional Society
- Institute of Validation Technology (IVT)
- American Society of Health-System Pharmacists
- The American Society of Mechanical Engineers (ASME)
- American Society for Quality (ASQ) Biomedical Division
- American Association of Pharmaceutical Scientists (AAPS)
- Consumer Healthcare Products Association (CHPA)
- Generic Pharmaceutical Association (GPhA)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Biotechnology Industry Organization (BIO)
- International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
- International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)
- International Regulatory Agencies
U.S. Government Agencies
- FDA
- FDA WWW Main Server Search Page
- CDER -Drugs Division
- CBER -Biologics
- Center for Devices and Radiological Health
- FDA-Medical Device Quality Systems Manual
- 21 CFR Part 11
- FDA Inspection Guides
- GMP Initiative
- Process Analytical Technology (PAT) Initiative
- Most Recent Warning Letters
- Federal Register
- US Pharmacopeia - USP Chapter 797
- ASHP Compounding Resource Center
- American National Standards Institute
- National Institutes of Health
- Centers for Disease Control and Prevention
- United States Pharmacopeia (USP)
News Sources
- Pharmaceutical Online
- BioSpace, Inc.
- Quality Magazine
- Cal Lab Magazine
- MDL Medical Device and Diagnostic Industry Magazine
- Health/Medical Internet Search Engine
- FDA News.com
- http://www.ivtconferences.com/shop/scripts/IVT_join_list.asp
Baltimore Bioscience Community