Product Information 1.1 General Product Information Product or Material Name Manufacturer’s Name Vendor’s Product Code Product or Material Description cGMP Material Yes No ISO 9001 ISO13485 CFR 820 Other, please state If yes, which cGMP standards are followed Contact for Technical Information for Product or Material (Name, Phone Number, e-mail) Manufacturing, Packaging, Release Site and Supplier Information Additions can be made to this section, e.g. adding a Source Manufacturer” row. “Crude However, no deletions should be made. Mark any sections that are not applicable with “N/A”. 2.1 Supply Chain Information Completion Not Required If Box Checked Names and Locations of Sites Please include all sites – Site Addresses and Named Contact for each site. Crude Source Manufacturer Site Source Manufacturer Site(s) Further Processing Site. E.g. micronisation Repackaging Site(s)
Product Information 1.1 General Product Information Product or Material Name Manufacturer’s Name Vendor’s Product Code Product or Material Description cGMP Material Yes No If yes, which cGMP standards are followed ISO 9001 ISO13485 CFR 820 Other, please state Contact for Technical Information for Product or Material (Name, Phone Number, e-mail) Manufacturing, Packaging, Release Site and Supplier Information Additions can be made to this section, e.g. adding a “Crude Source Manufacturer” row. However, no deletions should be made. Mark any sections that are not applicable with “N/A”. 2.1 Supply Chain Information Completion Not Required If Box Checked Names and Locations of Sites – Please include all sites Site Addresses and Named Contact for each site. Crude Source Manufacturer Site Source Manufacturer Site(s) Further Processing Site. E.g. micronisation Repackaging Site(s)
160218-standard-supplier-raw-material-technical-questionnaire-1.docx