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Specifications Question Email, July 19, 2011 - Anascorp

 

From: Jennifer Spinella [jspinella@raretx.com]
Sent: Tuesday, July 19, 2011 3:35 PM
To: Fisher, Robert
Cc: Shields, Mark; Cordaro, Debbie
Subject: RE: Anascorp Specifications: Question
 
Thank you. This is what I needed to present to the manufacturing folks in Mexico. I will send you revised specifications hopefully before you leave the office today.
 
Jennifer
 
 
 
From: Fisher, Robert [mailto:Robert.Fisher@fda.hhs.gov]
Sent: Tuesday, July 19, 2011 12:05 PM
To: Jennifer Spinella
Cc: Shields, Mark; Cordaro, Debbie
Subject: RE: Anascorp Specifications: Question
 
 
 
Hi Jennifer. The original BLA had a cresol spec of (b)(4). Your response to CR item 80 indicated that the 'theoretical maximum level of cresol' was set at -----(b)(4)-. This is also reflected in the "Specifications for Bulk and Final Product after review.pdf" document included in the CR response from February 2011. 
 
 
 
It is imperative that the documentation (lot release documents, BPR, etc.) be very clear and consistent in terms of these specifications and procedures. This is exactly the type of thing that a Team Biologics inspector looks for.
 

 
From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Tuesday, July 19, 2011 14:21
To: Fisher, Robert
Subject: Anascorp Specifications: Question
 
Hi Robert,
 
Rita is telling me that the correct specification for cresol is (b)(4), not (b)(4). Can you tell me where you are getting this number? We are happy to change the specifications for both sulfate and cresol to ----(b)(4)------. Please confirm that this is acceptable and I will send you the revised package insert and lot release protocol template reflecting this change.
 
Thanks,
 
Jennifer
 
 
 
Jennifer Spinella, MT(ASCP), RAC
Vice President, Regulatory Affairs & Quality Assurance
Rare Disease Therapeutics, Inc.
9550 Cuyamaca Street, Suite 203
Santee, CA 92071
Phone: 619-328-5370
Fax: 619-328-5379
email: jspinella@raretx.com