Please attach 1) a manufacturing process-outline or flow chart, and Ref: 2) a general description of the conditions applied at 1.2 each manufacturing step. (include pH, temperature, Ref: etc.) Is the product derived from microbiological or cell 1.3 Yes No culture fermentations? 1.3.1 If Yes, please indicate type. If yes, are any components used in the culture media 1.3.2 Yes No derived from animal origin and may carry viruses? 1.3.2.1 If Yes, indicate name of animal origin material? Is any of the equipment used for processing or storage Yes No of the product in contact at any time with other materials of animal origin? 1.4 Describe cleaning of equipment and effectiveness against viruses: C2. Viral Testing Barrier Has any viral testing for material quality assessment 2.1 Yes No been performed? 2.2 Please attach CoA (or describe performed) Ref: Questionnaire completed by: NAME: TITLE: PHONE:
1.2 Please attach 1) a manufacturing process-outline or flow chart, and 2) a general description of the conditions applied at each manufacturing step. (include pH, temperature, etc.) Ref: Ref: 1.3 Is the product derived from microbiological or cell culture fermentations? Yes No 1.3.1 If Yes, please indicate type. 1.3.2 If yes, are any components used in the culture media derived from animal origin and may carry viruses? Yes No 1.3.2.1 If Yes, indicate name of animal origin material? 1.4 Is any of the equipment used for processing or storage of the product in contact at any time with other materials of animal origin? Describe cleaning of equipment and effectiveness against viruses: Yes No C2. Viral Testing Barrier 2.1 Has any viral testing for material quality assessment been performed? Yes No 2.2 Please attach CoA (or describe performed) Ref: Questionnaire completed by: NAME: TITLE: PHONE: