Tools & Resources

  Resources 

• American Association of Pharmaceutical Scientists (AAPS)
• America Chemical Society (ACS)
• Code of Federal Regulations (21 CFR Part:)
  • CFR Search
  • 11: Electronic Records; Electronic Signatures
  • 58: Good Laboratory Practice for Nonclinical Laboratory Studies
  • 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
  • 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
  • 320: Bioavailability and Bioequivalence Requirements
• Dissolution & Controlled Release of Drugs
  • Controlled Release Society
  • Dissolution Discussion Group
  • FDA Dissolution Method Database
• European Medicines Agency (EMA)
• Food and Drug Administration (FDA)
  • FDA Guidance Documents
  • FDA News
  • FDA Warning-Letters
• International Council for Harmonisation (ICH)
• PhRMA
• Validations
  • FDA – Process Validation: General Principles and Practices
  • FDA – Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry
  • Bioanalytical Method Validation Guidance for Industry
  • General Principles of Software Validation
  • ICH – Bioanalytical Method Validation
  • ICH – Validation of Analytical Procedures: Text and Methodology