Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Follow-up Response to 26 Jul 2021 FDA Query #10
PFIZER CONFIDENTIAL
Page 1Reference is made to Query Response #10from FDA Information Request received 26 July
2021 received via email from Laura Gottschalk, OhD (CBER/OVRR):
“Please clarify if any drug substance direct product contact items (e.g., single- use system,
tubing, gaskets, small parts) used in either are autoclave sterilized. I f so,
please provide the autoclave load validation summary report for the heat penetration studies.
Ensure that the heat penetration information includes a detailed description of each
autoclaved item (i.e., size and length of tubing, t ype of filter, size of container, wrapping in
bag, etc.), thermocouple and biological indicator placement locations, cycle parameters used
during validation and in normal production operations, validation acceptance criteria, results
and any deviations. ”
On 30 July 2021 Pfizer provided apartial response to this query. Due to the file size of some
of the attachments to Response #10, not all the supporting documents were able to be
submitted under the initial . The remaining supporting documents below are nowsubmitted
to complete response #10 :
090177e197b5f791\Approved\Approved On: 03-Aug-2021 01:25 (GMT)
(b) (4)
(b) (4
(b) (4)
FDA-CBER-2021-5683-1149482