125742 S2 M3 32p3 control critical steps in process mon control overview

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BNT162b2
3.2.P.3.4 Control of Critical Steps and Intermediates
In-Process Monitoring and Control –Overview
PFIZER CONFIDENTIAL
Page 13.2.P.3.4. IN-PROCESS MONITORIN G AND CONTROL –OVERVIEW
This section provides a description of the controls of critical steps employ ed during 
manufacture of BNT162b2 d rug product to ensure that product qualit y and integrit y are 
maintained. Process parameters andin-process tests that are used to control the process and 
drug product qualit y are provided in this section.   
Process parameters discussed in this section include all critical process parameters (CPP) as 
well as relevant non -CPPs . As described in Section 3.2.P.2.3 Process Risk Assessment 
Strategy , CPPs and relevant non -CPPs were identified using Cause and Effect Risk 
Assessment based on product/process knowledge and available data.  
see Module 2.3 I ntroduction to 
Quality  Overall Summary ). 
In-process tests for control (I PT-Cs) and in -process tests for monitoring (IPT -Ms) were used 
throughout the process to ensure consistent manufacturing. IPT- Cs are in-process tests used 
to control a quality  attribute/critical quality  attribute within a specified range so that it meets 
the desired drug product quality . The IPT-Cs have an associated acceptance criterion. The 
IPT-Cs are tabulated with their associated acceptance criteria in Section 3.2.P.3.4 L NP 
Production and Bulk Drug Product Formulation and Section 3.2.P.3.4 Fill and Finish. The 
test methods for I PT-Cs are described in Section 3.2.P.3.4 I n-Process Test Methods .
In addition to I PT-Cs, IPT -Mswere implemented throughout the process to ensure 
consistency  of the manufacturing process.  IPT -Ms are used to monitor a quality  attribute to 
either ensure it is consistent with previous process history  or to enable forward processing. 
The I PT-Ms may  have action limits. The IPT-Ms are described in Section 3.2.P.3.4 
In-Process Test Methods.
This section also provides information regarding process step  as described in 
Section 3.2.P.3.4 Process Step  – LNP Production andBulk Drug Product 
Formul ation and Section 3.2.P.3.4 Process Step  –Fill and Finish.
090177e19700a134\Approved\Approved On: 12-May-2021 08:11 (GMT)
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FDA-CBER-2021-5683-1149043