GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook

10PartGCP-Cover-1.jpg
1-933734-57-4

US FDA Title 21 CFR Parts

  • Part 11 Electronic Records
  • Part 50 Protection of human subjects
  • Part 54 Financial disclosure by clinical investigators
  • Part 56 Institutional Review Boards
  • Part 312 Investigational New Drug Application
  • Part 314 Application to the FDA to Market a New Drug

    International Conference on Harmonisation Regulations

  • ICH E2A Clinical Safety Data Management
  • ICH E6 (R1) Good Clinical Practice

















    Quantity   1 - 99     100 - 249     250 - 499     500 - 999     1000+  
    Price $9.90 $9.80 $9.70 $8.90 $7.90

    Quantity   


  • example: 211, ISBN, Drug, GMP, Etc. - Press Enter
    July Special Mix and Match GCP Device GMP GCP-DRUG Featured Publication
    • Guaranteed Lowest Price
    • Quantity Discounts Available
    • Always Current, Up-To-Date
    • Company Logos Available
    • Special Customizations
    • Pocket-sized 3.75" x 6.25"
    • Prep for FDA & Client Audits
    • Employee Training & Reference
    • Promotional "giveaways"
    • Tradeshows and meetings

    Our Valued Clients










    Return to the GMP Publications home page View your shopping cart Fax Order Form Send us your logo! Email Us