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PDA National Website
Useful Links
Please note that some of these websites require a membership to access premium content.
REGULATORY AGENCIES & REGULATIONS
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FDA
FDA Warning Letters Page
What's New at FDA
CDER Guidance Documents
CDER cGMP Regulations
Code of Federal Regulations
EMEA: European Medicines Agency
EC: European Commission
The Rules Governing Medicinal Products in the European Union
USP Website: United States Pharmacopeia
PROFESSIONAL ORGANIZATIONS
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PDA Website: Parenteral Drug Association - Visit the National Website!
AAPS Website: American Association of Pharmaceutical Scientists
GAMP Forum: Good Automated Manufacturing Process
ISPE Website: International Society for Pharmaceutical Engineering
ASQ - American Society for Quality
PUBLICATIONS / REPORTS
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IVT: Institute of Validation Technology
FDC Reports: Pink Sheet, Gray Sheet, Gold Sheet, Tan Sheet, etc.
Pharmaceutical Technology
STANDARDS ORGANIZATIONS
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AAMI Website: Association for the Advancement of Medical Instrumentation
Engineering Standards Statistical Handbook
International Conference on Harmonization (ICH)
ISO Website: International Organization for Standardization
NIST Website: National Institute of Standards & Technology
