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BNT162b2
3.2.P.5.3 Validation of Analytical Procedures
Overvie w
PFIZER CONFIDENTIAL
Page 13.2.P.5.3. OVERVIEW
Validation of anal ytical procedures was performed to ensure the composition, strength ,
identity , potency , purit y, and safet y of BNT162b2 drug product. All non -compendial and
compendial a nalytical procedures were confirmed suitable for their intended use .
Analy tical procedures were validated against the parameters presented in ICH Q2(R1),
Validation of Anal ytical Procedures: Text and Methodology , for the respective methodology
categories. Quantitative analy tical procedures were validated for precision, accuracy ,
specificit y, linearit y, range, and robustness.
Summaries of the non -compendial and microbiological compendial validations /verifications
performed for BNT162b2 drug product release and stability anal ytical procedures are
provided in this section , except which are
provided in Section 3.2.S.4.3 Validation of Anal ytical Procedures. As requested by FDA, the
analytical method validation and transfer reports are presented in Section 3.2.R Standard
Operating Procedures, Method Validation and Transfer Reports .
090177e19700a785\Approved\Approved On: 12-May-2021 07:25 (GMT)
(b) (4)
(b) (4)
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FDA-CBER-2021-5683-1149281