美国FDA 指导原则 提交用于输血或进一步制造的人血和血液成分的化学、制造和控制以及设施描述信息，并用于填写表格FDA 356 英文原版.pdfVIP

Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use” Additional copies are available from: Office of Communication, Training and Manufacturers Assistance (HFM-40) 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 301/827-1800 or 1/800/835-4709 (Internet) /cber/guidelines.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) May 1999 TABLE OF CONTENTS [Note: Page numbering may vary for documents distributed electronically.] GENERAL INFORMATION Page No. I. BACKGROUND 1 II. DEFINITIONS 2 III. DIRECTIONS FOR COMPLETING FORM FDA 356h A. When to use 5 B. Submission recommendations 6 C. Detailed instructions – front of Form FDA 356h 6 D. Detailed instructions – back of Form FDA 356h 12 PART I – CHEMISTRY, MANUFACTURING AND CONTROLS SECTION I. PRODUCTS INCLUDED IN “BLOOD BLOOD COMPONENTS” BLA 15 II. MANUFACTURING PROCEDURES COMMON TO MULTIPLE TRANSFUSION COMPONENTS A. Irradiation 16