
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

 