Filing Memorandum - Spherusol
File STN BL STN 125354/0
Deborah Trout, Committee Member, CBER, OCBQ, DMPQ, HFM-675
Carolyn Renshaw, Branch Chief, MRB1, DMPQ, OCBQ, HFM-675
Initial review of Allermed Laboratories Inc., eBLA for Coccidioidan Skin Test to determine its acceptability for filing.
- Description of the overall process for the filling, capping and aseptic assembly of the Drug Product.
- Description of the washing, sterilization and depyrogenation process and associated validation data for containers, closures and equipment.
- Procedures, specifications and data for aseptic processing and media fills (sterile bulk and final fill).
- Method and results demonstrating container closure integrity.
- Process Validation; a summary including protocol and test results should be provided for the validation studies of each critical process or factor that affects the Drug Product.
- A description of container/closure compatibility with the drug product to include results of compatibility and toxicity.
- Cross Contamination Issues; cleaning procedures and validation data for product contact equipment. Is product contact equipment shared or dedicated?
- Containment Features; this section should contain a description of segregation and containment procedures for areas, manufacturing operations, personnel, equipment and waste materials designed to prevent contamination of products.