Schedule D

(1) The production area and the viral inactivation room shall be centrally air-conditioned and fitted with HEPA filters having Grade C (Class 10,000) environment as given in the Table below. (2) The filling and sealing shall be carried out under aseptic conditions in centrally air-conditioned areas fitted with HEPA Filters Grade A or, as the case may be, Grade B (Class 100) environment given in the said Table. [TABLE: AIR CLASSIFICATION SYSTEM FOR MANUFACTURE OF STERILE PRODUCTS] Grade A (Class 100) (Laminar - Airflow workstation): 3500 (0.5 – 5 micron), None (Less than 5 micron), Less than 1 (Max Viable Micro-organism per m3). Grade B (Class 100): 3500 (0.5 – 5 micron), None (Less than 5 micron), Less than 5 (Max Viable Micro-organism per m3). Grade C (Class 10,000): 3,50,000 (0.5 – 5 micron), 2000 (Less than 5 micron), Less than 100 (Max Viable Micro-organism per m3). (3) The physical and chemical operations used for the manufacture of plasma fractionation shall maintain high yield of safe and effective protein. (4) The fractionation procedure used shall give a good yield of products meeting the in-house quality requirements as approved by the Licensing Authority and Central Licence Approving Authority reducing the risk of microbiological contamination and protein denaturation to the minimum. (5) The procedure adopted shall not affect the antibody activity and biological half-life or biological characteristics of the products.