1.

Agreement between Manufacturer and SRS PH (or Tripartite) including list of products for supply in
the Philippines.
2. GMP Certificate from country of origin and PIC/s issued (both apostilled from issuing country).*
3. Copy of the last inspection report and the manufacturer's response to any deficiencies noted.
4. A copy of the Validation Master Plan (Covering process media fill (if relevant) cleaning, computerized
system, or as applicable and Risk Assessment used to determine the scope and extent of validation.
5. Rationale for Test Method validation procedure for method transfer etc.
6. Copies of the procedures for handling deviation and out of specification test results.
7. A copy of Site Master File or equivalent

*If Apostillation is not available, a commitment letter must be provided.