Requirements for Pharma Dossier-Cambodia

ByPharma DRA

Pharma DRA technical team will take 07 working days after Bangladeshi Manufacturer provides us the list of required documents:

  1. COPP
  2. WHO GMP
  3. Spec of FP
  4. MOA of FP and Analytical method validation protocol/report with chromatogram data (available data only)
  5. API Specification with COA-Supplier & Formulator, API DMF, GMP & LOA (Letter of Access)
  6. MFR/BMR/QNQ (with Blank word copy)
  7. Primary packaging in brief
  8. Primary pack. material details & styles
  9. Manufacturing license (25 &/or, 28)
  10. Artwork
  11. Site master file
  12. Batch numbering system, SOP
  13. List of equipment
  14. RS/working standard certificate with IR data.
  15. Filled BMR with scan copy (Version must be similar with Master COPY)
  16. Process Validation protocol or report (if any)
  17. Shelf life and Label claim
  18. Letter of Authorization, Cover letter & CVs, Designation of experts (Clinical & Technical person)
  19. Product permission/MA
  20. Agreement, if Any
  21. Product development report and formulation development report (available data only)

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