125742 S2 M2 drug product reference stand or materials
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BNT162b2 2.3.P.6 Reference Standards or Materials PFIZER CONFIDENTIAL Page 12.3.P.6. REFERENCE STANDARDS OR MATERIALS 2.3.P.6.1. Clinical Reference Material The drug substance reference material detailed in Section 3.2.S.5.1 Reference Standards or Materials is used for DP release and stability testing in the Fluorescence assay . Lipid reference mate rials, and used for the release and stability testing of drug product arepresented in Table 2.3.P.6 -1. Table 2.3.P.6 -1. Summary of Lipid Reference Materials Reference Mater ial Designation Supplier Types of Material Released/Evaluated ALC -0315 Reference Material Clinical Supplies, Process Validation , EUA SuppliesDP ALC -0159 Reference Material Clinical Supplies, Process Val idation , EUA SuppliesDP DSPC Ref erence Material Clinical Supplies, Process Validation , EUA SuppliesDP Cholesterol Reference Material Clinical Supplies, Process Validation , EUA SuppliesDP Sectio n 3.2.A.3.5 Ref erence Standards or Materials [AL C-0315] describes qualification information of AL C-0315 reference material. Section 3.2.A.3.5 Reference Standards or Materials [AL C-0159] describes qualification information of AL C-0159 reference material. Future lots of A LC-0315 and ALC-0159 reference material s will be sourced from an appropriatel y qualified vendor and qualified to ensure the same level quality of materials . Reference Section 3.2.P.6 Qualification of Future Reference Standards for further information on qu alification of the lip id reference materials . Cholesterol for use as a reference material will be sourced from an appropriately qualified vendor. Future lots of cholesterol reference ma terial will meet the USP or Ph. Eur. requirements for cholesterol. Future lots of DSPC for use as a reference material will be sourced from an appropriatel y qualified vendor and will meet the acceptance criteria for current vendors outlined in Section 3.2.P.4.1. Specifications (Non -Compendial). The period of use applied to new lipid materials will be assigned based 090177e19702f8c6\Approved\Approved On: 12-May-2021 07:54 (GMT) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1148985