125742 S40 M1 response 06aug2021
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COVID -19 Vacc ine (BNT162, PF -07302048) BLA 125742/0 Response to 06Aug 2021 FDA IR Regarding two drug product (DP) documents PFIZER CONFIDENTIAL Page 1QUERY 1 We note the following statement quoted below in your document 3.2.P.2 Manufacturing Process Development –Process Development and Characterization on page 47: “For more efficient processing, the software at Pfizer Puurs was updated to introduce a step, independent of the selected batch size, ” This step was validated in coupled with the process validation for a drug product batch size at Pfizer Puurs (data submitted to EUA 27034 amendment 116 on March 29, 2021). However, the process validation for the batch size was not executed with this step. Please clarify that during the routine commercial -scale manufacturing process, the step is only applied to the batch scale at Pfizer Puurs. Please also update the document 3.2.P.3.3 Description of Manufactu ring Process and Process Controls –LNP Production and Bulk Drug Product Formulation [Puurs] to clearl y describe at which batch scale the step will be performed. RESPONSE 1 The applicant confirms that the step willonly be executed during manufacturing of the batch size. An updated 3.2.P.3.3 Description of Manufacturing Process and Process Controls – LNP Production and Bulk Drug Product Formulation [Puurs] is provided. Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation 3.2.P.3.3 Description of Manufacturing Process and Process Controls –LNP Production and Bulk Drug Product Formulation [Puurs] , replaced Previously submitted supporting documentation None 090177e197c468b2\Approved\Approved On: 10-Aug-2021 01:15 (GMT) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149525