Rabu, 24 Agustus 2011

Requirement Documents For Imported Food Supplement Registration in BPOM Indonesia

Administration Documents:
1.  Certificate of Manufacturer Licensed for TMs or Pharmaceutical or certificate of Importer Licensed for TMs or Pharmaceuticals Product or Food
2.  Letter of Authorization, legalized by Indonesian Embassy
3. Certificate of Free Sale, issued by Government
4. Good Manufacturing Practice (GMP) certificate, issued by manufacturer of country of origin
5. ISO certificate

Technical Documents:
1. Composition : active ingredients, additive / excipient in matrix
2. Direction of use : the direction of use dosage, warning, precaution, contraindication / recommendation and duration of administration, if any
3. Manufacturing process : started from weighing of raw material to finished product
4.Certificate of Analysis of Formula's ingredients / raw material
5. Analysis method of active ingredient
6. Finished product evaluation: certificate of analyzed finished product (organoleptics, physical-chemical, microbial, and heavy metal contaminant) 
7. Analysis method of fisnished products
8. Analysis method and data of stability test of finished product (room temperature / accelerate)
9. Packaging design and packaging specification
10. Batch/lot numbering system
11. Certificate of microbial contaminant test result from laboratorium which has appointed by NADFC/BPOM
12. Toxicity test data for food supplement which its safety has not known from laboratorium which has appointed by NADFC/BPOM or from country of origin.
13. Samples

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