Information Request for BLA125478/0, February 25, 2014 - Ragwitek

From: Rivers, Katie
Sent: Tuesday, February 25, 2014 10:11 AM
To: 'Greenfeder, Scott'
Cc: Valenti, Elizabeth; Chattopadhyay, Rana; Trout, Deborah
Subject: Information Request for BLA125478/0

Dear Scott,
Regarding the ALK/Merck Ragwitek validation strategy described in your memo dated February 18, 2014; please clarify if the Ragwitek validation strategy (i.e., --b(4)-------------------------------------------------------------- used to validate US DP lots) was prospectively defined in a process validation protocol. If your protocol does not clearly identify this strategy please provide a protocol for retrospectively validating the process. Please note that batches selected for retrospective validation should be representative of all batches made during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency. Retained samples can be tested to obtain data to retrospectively validate the process.
Please let me know if you have any questions.

Thank you, 
Katie
Katie H. Rivers, M.S.
Regulatory Project Manager, CMC1
FDA/CBER/OVRR/DVRPA
1401 Rockville Pike, HFM-481
Rockville, MD 20852
Phone 301-796-2640
Fax 301-827-3532
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