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GMP clearance for overseas manufacturers

Book pagination

16 May 2011

Appendix G - Flow chart for GMP clearance

Appendix G - Flow chart for GMP clearance (pdf,93kb)

Text version of flowchart

This text representation of this flowchart is provided as a list with numbered steps.

Overseas Site requiring a GMP clearance

  1. Who is the certifying authority?
    • MRA Country? (Go to Step 2)
    • PIC/S regulators outside own country
      US FDA, Medsafe complementary medicines
      Non-PIC/S regulators
      No Certification? (Go to Step 3)
    • US FDA all locations, not complementary medicines
      Medsafe in NZ only, not complementary medicines
      PIC/S Regulators in own country only? (Go to Step 5)
  2. For a site in their own country?
    • Yes? (Go to Step 4)
    • No? (Go to Step 5)
  3. TGA On-site audit - End flow chart
  4. MRA Clearance Evidence list A: Current GMP Certificate - End flow chart
  5. Compliance verification
    • What step(s) is the facility performing for the product?
      • Evidence List B
        • Current GMP Certificate
        • List of all regulatory inspection conducted in last three years and copy of most recent inspection/audit report
        • Site Master File
        • GMP Agreement between sponsor and manufacturer
        • Details of any regulatory actions in last three years
        • List of products intended for supply in Australia
        • Copy of Release for Supply procedures for products in application - End flow chart
      • Evidence List C
        • Validation Master Plan
        • Latest Product Quality Review - End flow chart
      • Evidence List D
        • Current GMP Certificate
        • List of all regulatory inspection conducted in last three years and copy of most recent inspection/audit report
        • Quality or Laboratory Manual
        • GMP Agreement between contract site and manufacturer
        • A list of tests the laboratory is authorised to perform
        • Details of any regulatory actions in the past three years - End flow chart

Book pagination