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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 19, 2012 - Q-Pan

 

Submission Type: BLA    Submission ID: 125419/0    Office: OVRR
Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Applicant:
ID Biomedical Corporation of Quebec
Telecon Date/Time: 19-Dec-2012 02:30 PM        Initiated by FDA? Yes
Telephone Number: 888 643 3083
Communication Categorie(s):
1. Information Request
 
Author: KIRK PRUTZMAN
Telecon Summary:
IR regarding cleaning validation information.
FDA Participants: KIRK PRUTZMAN, RANDA MELHEM, CARMEN COLLAZO, JEREMY WALLY
Non-FDA Participants: MICHAEL SCHWARTZ, TERRY WARD
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
CBER called GSK to discuss issues relating to cleaning validation and environmental monitoring.
  1. In your response to the 30-Nov-2012 information request you stated (Amendment 125419/0/22) that the (b)(4) method was not performed during the cleaning validation because “at the time the cleaning validation was performed the analytical method for testing a specific (b)(4) for the removal of (b)(4) was not available”. However several of the submitted cleaning validation reports have          (b)(4) testing data. Please clarify. GSK stated that they implemented ---------------------(b)(4)------------------------, and added that they will review their cleaning validation procedures and reports submitted and get back to CBER.
  2. CBER asked GSK to justify not using (b)(4) approach for the cleaning validation of equipment, and to explain why the approach they use is acceptable. GSK understood and said that they would look into the issues and get back to CBER.
  3. CBER asked GSK to clarify the labeling of the tanks used for the manufacture of AS03. For example, for -----(b)(4)---------, the following Tags were listed:             -------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------. GSK understood and committed to provide CBER with a comprehensive list of equipment used (their IDs) and equipment cleaning records.
  4. You provided in Amendment 125419/0/22 report RX 20070513, Environment qualification of the room ---(b)(4)---------, where several deviations, were reported and not fully described. Please describe the deviations and justify why you consider the validation as conform even though you reported deviations on 11 of the (b)(4) days tested. GSK stated that they will review the data and get back to CBER.
 
GSK stated that they will provide their response in January 2013.