Requirement for pharma dossier-Chad (North & Central Africa)

ByPharma DRA

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

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

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