4.12 Potential for Economic Adulteration Completion Not Required If Box Checked What controls are in place to assure that Yes; Explain: the materials produced at or shipped from this facility are not adulterated, e.g. melamine, PEG, Jatropha, etc? None Is the material supplied at risk for Yes; Explain: melamine contamination (FDA guidance - Pharmaceutical components at risk for melamine contamination) None If yes, which measures are in place to monitor its absence in the material supplied? Section 5: Miscellaneous Product Information 5.1 Lot/Batch Definition Completion Not Required If Box Checked
4.12 Potential for Economic Adulteration Completion Not Required If Box Checked What controls are in place to assure that the materials produced at or shipped from this facility are not adulterated, e.g. melamine, PEG, Jatropha, etc? Yes; Explain: None Is the material supplied at risk for melamine contamination (FDA guidance - Pharmaceutical components at risk for melamine contamination) If yes, which measures are in place to monitor its absence in the material supplied? Yes; Explain: None Section 5: Miscellaneous Product Information 5.1 Lot/Batch Definition Completion Not Required If Box Checked
160218-standard-supplier-raw-material-technical-questionnaire-1.docx