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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 25, 2013 - RIXUBIS

 

From:                              Thompson, Edward
Sent:                               Thursday, April 25, 2013 7:34 AM
To:                                  'Kevin Smyth (kevin_smyth@baxter.com)'
Cc:                                  Ovanesov, Mikhail V.; Amin, Pankaj (Pete)
Subject:                          Information Request for BL 125446/0
 
Contacts:                        Kevin Smyth
 
Dear Mr. Smyth:
 
We are reviewing your August 28, 2012 biologics license application (BLA). We are providing the following comments and request for additional information to continue our review:
 
Environmental Monitoring (EM) Program
 
The BLA states that the environmental monitoring was performed per SOP ---b(4)-------- Environmental Air (HVAC) for aseptic processing in the –b(4)---------------- and per SOP---b(4)-------------------, Environmental Monitoring Program for –b(4)-----------------------, -----b(4)-------------------------------------------------------------------------------------, for an ISO b(4)/Grade b(4) environment.
 
1.     Please provide (in table format) frequencies of testing for viable and nonviable particulate monitoring parameters; viable and nonviable particulate action and alert limits for production operations for each manufacturing areas.
 
2.     Please provide summary of routine monitoring program for personnel monitoring in the aseptic filling areas.
 
3.     Please provides EM data summary for the conformance lots including investigation of environmental excursions.
 
4.     Please provide environmental monitoring data summaries for the Formulation and finishing facility shutdown and startup activities (for year 2012 or most recent).
 
5.     Please describe your procedure how EM data are trended and reviewed by the quality assurance.
 
6.     Please briefly describe how you perform microbial identification for microbial counts that exceed the action level.
 
7.     EM nonconforming report # TNA12003A/NCR94337 (04/24/12) describe the viable air sample in room –b(4)------------------ area) resulted in an out-of-level condition with b(4) molds and b(4) CFU per cubic meter. Please provide describe any other EM nonconforming where you –b(4)--- since completion of conformance runs (process validation) in your –b(4)----------------------------------------------------------------------------------------------------------.
 
Media fill
 
You have completed the process simulation runs (media fills) to qualify the aseptic filling process on Filling –b(4)-------------- the aseptic support and production rooms per Protocol –b(4)------------, Aseptic Process Media Fills on Fill –b(4)------ for the 10mL Vials (--b(4)---------) and ---b(4)----------------------------). These process simulation runs (---b(4)------------------------------------------------------- were conducted between July 7, 2010 and July 13, 2010. 
 
8.     Please provides the process simulation runs summary to qualify the aseptic filling process on Filling –b(4)----------- (per Protocol –b(4)--------------, Aseptic Process Media Fills on Fill –b(4)----- for the 10mL Vials (--b(4)--------) and –b(4)---------) that was conducted after July 13, 2010. Your media fill summary should include lot number, fill date, batch size, lyophilizer used, number of units filled, number units incubated, number of units rejected for cause, media growth promotion verification, number of contaminated units. 
 
9.     Please provide investigation detail if you have any incident of failed media fill.
 
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. 
 
Please submit your response to this information request as an amendment to this file by May 9, 2013 referencing the date of this request. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
 
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing.
 
The action due date for this file is tentatively June 30, 2013.
 
Please send an acknowledgement message for receipt of this request.
 
If you have any questions, please contact me at (301) 827-9167.
 
Sincerely,
 
 
Edward Thompson
Regulatory Project Manager
FDA/CBER/OBRR/DBA/RPMB
 
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