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From: Smith, Michael (CBER)
Sent: Friday, August 13, 2021 3:36 PM
To: Aghajani Memar, Neda <[email protected]>; Rohlfing, Paul
<[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Harkins Tull, Elisa <[email protected]>; Devlin, Carmel M
<[email protected]>
Subject: STN 125742.0: 7 facility questions from the DMPQ team
Neda and Paul,
The DMPQ review team has the below seven facility questions. Please respond as
soon as possible and no later than noon on Tuesday, Aug ust 17, 2021.
Drug Substance (Pfizer Andover; ):
1. Regarding the computer systems, please provide the following:
a. A list of the critical BNT162b2 drug substance manufacturing steps that are
computer -controlled with the computer system ident ified.
b. For each computer system identified in Part 1a, provide a narrative description of the validation process, certification that the installation and
operational qualification (IQ and OQ) have been completed; explanation of
the parameters monitored and tests performed; and a validation data
summary.
2. For each cold room, freezer, and freeze/thaw system in
in ) used in the manufacture of the BNT162b2 drug substance,
please identify the equipment with its unique identifier and provide a concise
description of the qualification (e.g., IQ, OQ, performance qualification (PQ)).
Drug Product (Pfizer Puurs and Kalamazoo)
3. Regarding the recent Information Request (IR) responses (Response to FDA 26 Jul 2021 and Response to the Augus t 5, 2021 FDA IR) STN 125742/0.24
and STN 125742/0.43, the Agency has additional inquiries for the
Kalamazoo facility. You provided Table 8 (appended in the Response to
August 5, 2021 FDA IR), which lists the BNT162b2 product contact equipment. Please pr ovide the operational and performance qualification
(OQ/PQ) summary documents for all new pieces of equipment. In addition,
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150247
please provide representative OQ/PQ summary documents for all families
or groupings of tanks, regardless of whether they are existi ng or new.
4. Regarding the equipment utilities at Pfizer -Kalamazoo please provide the
following information:
a. Please provide the WFI/PW water quality criteria and a description of the monitoring program.
b. Please provide all uses of the compressed air and nitrogen specific to BNT162b2 manufacture. If the respective utility is used in the process, please provide the monitoring limits.
5. Regarding the cleaning validation summary for the direct product -contact
equipment at Pfizer -Kalamazoo, please provide the f ollowing information:
a. Please provide the data to support the validated clean hold times for all direct product -contact equipment.
b. Please explain why the acceptance criterion for residual cleaning
agent is higher for the BNT162b2
) than it is for the other equipment
).
6. Re
garding visual inspection of the BLA process validation lots of BNT162b2
filled vials at Pfizer -Kalamazoo, please provide the following information:
a. Please describe which PPQ/proc ess validation lots were 100% visually
inspected by automated inspection and which lots were 100% visually inspected manually.
b. Please provide the acceptance criteria for the allowable limit of
rejects during visual inspection.
c. Please provide the defect/reject categories and the percentage of the rejects in each category for each BLA process validation lot.
7. Please update section 3.2 A.1 with the current cleaning validation status at
Pfizer Puurs. Please update the status of your microbiological cleaning
validation, outstanding manual cleaning and any cleaning validation deviation information, as applicable.
Regards,
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150248
Mike
- Please confirm receipt of this e -mail and let us know if you have any
questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug Administration
Center for Biologics Evaluation & Research
Office of Vaccines Research & Review
Division of Vaccines and Related Products Applications Tel: 301- 796-2640
[email protected]
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FDA-CBER-2021-5683-1150249