Pharma DRA technical team will take 07 working days after Bangladeshi Manufacturer provides us the list of required documents:
- COPP
- WHO GMP
- Spec of FP
- MOA of FP and Analytical method validation protocol/report with chromatogram data (available data only)
- API Specification with COA-Supplier & Formulator, API DMF, GMP & LOA (Letter of Access)
- MFR/BMR/QNQ (with Blank word copy)
- Primary packaging in brief
- Primary pack. material details & styles
- Manufacturing license (25 &/or, 28)
- Artwork
- Site master file
- Batch numbering system, SOP
- List of equipment
- RS/working standard certificate with IR data.
- Filled BMR with scan copy (Version must be similar with Master COPY)
- Process Validation protocol or report (if any)
- Shelf life and Label claim
- Letter of Authorization, Cover letter & CVs, Designation of experts (Clinical & Technical person)
- Product permission/MA
- Agreement, if Any
- Product development report and formulation development report (available data only)
