Guidance for Industry: For the Submission of Chemistry, Manufacturing and211 Controls and Establishment Description Information for Human Plasma-Derived 211 Biological Products, Animal Plasma or Serum-Derived Products

摘要

;Contents: General information; Background; Definitions; Chemistry, Manufacturing211u001eand Controls Section (Introduction, Biological substance/product, Investigational 211u001eproduct/formulation, Environmental assessment, Method validation); Establishment 211u001eDescription Section (Introduction, General Information, Specific Systems); 211u001eAppendix A.