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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Memorandum - Spherusol

  
 To:   


File STN BL STN 125354/0
 


From:   

 
Deborah Trout, Committee Member, CBER, OCBQ, DMPQ, HFM-675

 

Through:   


Carolyn Renshaw, Branch Chief, MRB1, DMPQ, OCBQ, HFM-675
Subject: 
Initial review of Allermed Laboratories Inc., eBLA for Coccidioidan Skin Test to determine its acceptability for filing.

 

I have completed an initial review of the application and recommend that the eBLA should not be filed based on the missing information noted below.
 
The following information required by “Guidance for Industry for the submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products” was not provided:
 
  • 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.

     
The following information required by “Guidance for Industry on the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test” was not provided:

 
  • 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.