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)
4.3 Dedication of Equipment at Re-packager Is the material repackaged on equipment? Yes No; Explain what other materials are produced on the same equipment and how cross-contamination is prevented: 4.4 Origin of Material Completion Not Required If Box Checked Does the product involve the use of materials (i.e. Animal, Human Origin, or other biological e.g. microbial fermentation)? Yes; Please complete this form, plus Adventitious Agents Addendum No; Please complete this form only Dedication of Equipment at Source Manufacturer: Is the material manufactured on equipment? Yes No; Explain below what other materials are processed on the same equipment and how cross-contamination prevented: Is the material packed on equipment? Yes No Dedication of Equipment at Re-Packager: Is the material repackaged on equipment? Yes No; Explain what other materials are produced on the same equipment and how cross-contamination is prevented:
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
Does the lot/batch number follow a specific format that implies additional information (e.g., first 2 digits represent month of manufacture, etc.)? Yes; Explain: No Definition of a Time frame within continuous processing Unique lot/batch production Per final package fill Other; Explain: Minimum Lot/Batch Size Maximum Size 5.2 Technically Unavoidable Particles Completion Not Required If Box Checked Has an assessment been performed for technically unavoidable/inherent particles? Yes; Explain: No Please list (or attach) a list of materials that are technically unavoidable particles:
1.2 Is the product partially or fully of animal origin (i.e. tissue, tissue extract or fluid such as milk, serum, blood etc.)? Yes No 1.2.1 If Yes, provide type of tissue or animal component: 1.2.2 Is the material primary or secondary origin? Primary Secondary Tertiary Non applicable 1.3 Does the manufacturing process involve any raw materials, source materials, or reagents that are of animal origin? Yes No 1.3.1 If Yes, provide type of tissue or animal component: 1.4 Is the product derived from microbiological or cell culture fermentations? Yes No 1.4.1 If Yes, please indicate type. 1.4.2 If yes, are any components used in the culture media derived from animal origin? Yes No 1.4.2.1 If Yes, indicate name: 1.5 Is the product purified using chromatography media (e.g. specific ligand columns) or buffers that contain components of animal origin? Yes No 1.5.1 Or any other processing/Formulation containing components of animal origin? Yes No 1.6 Is the product, for any other reason, at any time, in contact with materials of animal origin? Yes No 1.6.1 Please provide details