BLA Questions on Equipment - TachoSil, March 12, 2010
 
BLA QuestionFrom: ---------------(b)(4)----------------
 Sent: Friday, March 12, 2010 9:52 AM
 To: O'Lone, Martha (CBER)
 Cc: He, Jie; Carrie Langlais
 Subject: RE: BLA Questions on equipment

Attachments: Nycomed- FDA response CMC Information Request.pdf; Nycomed- draft-inner-blister-label-midi.pdf; Nycomed-draft-inner-blister-label-large.pdf

Dear Captain O'Lone,

Attached please find the responses to your information request.

I am also enclosing the draft inner blister label for the midi and large pack sizes. If at all possible, we would very much appreciate receiving your pre-approval on these labels (today? Monday) so we can start printing Monday or early next week.

We appreciate your review and work on our BLA.

Kind regards,

-(b)(4)-

 

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 From: O'Lone, Martha (CBER) [mailto:Martha.OLone@fda.hhs.gov]
 Sent: Tuesday, March 09, 2010 8:43 AM
 To: ---(b)(4)---
 Cc: He, Jie
 Subject: RE: BLA Questions on equipment


Hi --(b)(4)---

Please add -(b)(4)- to the information request for Nycomed. I will need the same information on -(b)(4)- validation for the submission that I requested yesterday for some other manufacturing equipment. Please provide a description of the -(b)(4)- equipment, the dates for IQ/OQ/ PQ, the acceptance criteria for PQ, a summary of the test results, and a summary of any deviations (if deviations occurred, a summary of the investigation, resolution).

Thanks for your attention to this matter.

Martha

CAPT Martha O'Lone, BSN, R.N.

Director Regulatory Review

FDA/CBER/DMPQ

301-827- 3031

 




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From: ------------(b)(4)---------------------
 Sent: Monday, March 08, 2010 2:08 PM
 To: O'Lone, Martha (CBER)
 Cc: He, Jie
 Subject: RE: BLA Questions on equipment

 

Dear Captain O'Lone,

 

This is to acknowledge receipt of your e-mail. I will forward it on immediately to Nycomed.

 

Kind regards,

 

-(b)(4)-




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From: O'Lone, Martha (CBER) [mailto:Martha.OLone@fda.hhs.gov]
 Sent: Monday, March 08, 2010 1:45 PM
 To: --(b)(4)--
 Cc: He, Jie
 Subject: RE: BLA Questions on equipment
 Importance: High

Hi --(b)(4)---

Please forward the following information request to Nycomed. This information will be needed by this Friday 12 March.

The submission does not contain some of the following details for the manufacturing equipment used in TachoSil production.

Please provide a brief summary of the following information for the equipment used in manufacture of TachoSil BLA;

The dates for IQ/OQ of the equipment in the TachoSil production area,

The dates that PQ was completed,

 

In the submission the Process Validation Summary Report 0903X-VB- 00000001-01 dated 12 April 2009, appears to include the following PQ information for some of the equipment on this list. (If it is included in the Process Validation report, I will only need the dates for IQ/OQ/PQ for the equipment.) If it was not included in this TachoSil Process summary validation report, please provide;

A description of the equipment, the dates for IQ/OQ/ PQ, the acceptance criteria for PQ, a summary of the test results, and a summary of any deviations (if deviations occurred, a summary of the investigation, resolution)

 

This is the list of equipment;

-------(b)(4)-------

Autoclaves and Sterilizers in Room -(b)(4)-

------------(b)(4)---------------

Coating Equipment

Vacuum Dryers- -(b)(4)-. If identical, please provide one set of information and state that the others are identical/ dates for IQOQPQ of others.

-(b)(4)- Cutting Machine

Packaging line equipment for both --(b)(4)- unit --(b)(4)-- for TachoSil and for Primary and Secondary Pkg equipment in Rooms --(b)(4)--.

 

Please provide the response by email and I will let you know if it should be submitted as an amendment.

 

 

Thanks for your assistance,

Martha

 

CAPT Martha O'Lone, BSN, R.N.

Director Regulatory Review

FDA/CBER/DMPQ

301-827- 3031

 

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