Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 2
QUERY 1 ................................ ................................ ................................ ................................ ...3
RESPONSE 1 ................................ ................................ ................................ ................... 3
QUERY 2 ................................ ................................ ................................ ................................ ...4
RESPONSE 2 ................................ ................................ ................................ ................... 4
QUERY 3 ................................ ................................ ................................ ................................ ...5
RESPONSE 3 ................................ ................................ ................................ ................... 5
QUERY 4 ................................ ................................ ................................ ................................ ...6
RESPONSE 4 ................................ ................................ ................................ ................... 6
QUERY 5 ................................ ................................ ................................ ................................ ...7
RESPONSE 5 ................................ ................................ ................................ ................... 7
QUERY 6 ................................ ................................ ................................ ................................ ...8
RESPONSE 6 ................................ ................................ ................................ ................... 8
QUERY 7 ................................ ................................ ................................ ................................ .10
RESPONSE 7 ................................ ................................ ................................ ................. 10
QUERY 8 ................................ ................................ ................................ ................................ .11
RESPONSE 8 ................................ ................................ ................................ ................. 11
QUERY 9 ................................ ................................ ................................ ................................ .12
RESPONSE 9 ................................ ................................ ................................ ................. 12
QUERY 10 ................................ ................................ ................................ ............................... 13
RESPONSE 10 ................................ ................................ ................................ ...............13
QUERY 11 ................................ ................................ ................................ ............................... 15
RESPONSE 11 ................................ ................................ ................................ ...............15
QUERY 12 ................................ ................................ ................................ ............................... 16
RESPONSE 12 ................................ ................................ ................................ ...............16
QUERY 13 ................................ ................................ ................................ ............................... 17
RESPONSE 13 ................................ ................................ ................................ ...............17
QUERY 14 ................................ ................................ ................................ ............................... 21
RESPONSE 14 ................................ ................................ ................................ ...............21
QUERY 15 ................................ ................................ ................................ ............................... 22
RESPONSE 15 ................................ ................................ ................................ ...............22
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
FDA-CBER-2021-5683-1149408
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 2QUERY 16 ................................ ................................ ................................ ............................... 23
QUERY 16A................................ ................................ ................................ ............................ 23
RESPONSE 16a ................................ ................................ ................................ .............23
QUERY 16B ................................ ................................ ................................ ............................ 24
RESPONSE 16b ................................ ................................ ................................ .............24
QUERY 16C ................................ ................................ ................................ ............................ 25
RESPONSE 16c ................................ ................................ ................................ .............25
QUERY 16D ................................ ................................ ................................ ............................ 26
RESPONSE 16d ................................ ................................ ................................ .............26
QUERY 16E ................................ ................................ ................................ ............................ 27
RESPONSE 16e ................................ ................................ ................................ .............27
QUERY 16F ................................ ................................ ................................ ............................. 31
RESPONSE 16f ................................ ................................ ................................ ..............31
LIST OF TABLES
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FDA-CBER-2021-5683-1149409
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 3QUERY 1
Please clarify whether the can be stored. If so, please provide
details regarding the container closure that is used for the storage of the materials and the
maximum storage time.
RESPONSE 1
Both the may be stored prior to further processing.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149410
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 4QUERY 2
Please provide information on the container closure used for the as this
material is shipped for further processing.
RESPONSE 2
The is stored in containers with a
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149411
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 5QUERY 3
Please provide the maximum hold time for each manufacturing step of the
and provide hold time study data for an y hold greater than 24
hours.
RESPONSE 3
The manufacturing steps of the are routinely performed
.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149412
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 6QUERY 4
Regarding manufacturing, please provide the in -process action limit for
bioburden and endotoxin.
RESPONSE 4
In-process bioburden and endotoxin samples are evaluated at the steps as described in Table
3.2.S.2.3- 7. Process Flow for . If in-process bioburden results of
are exceeded then an investigation
is opened to determine product impact, identify root cause, and evaluate relevant preventative
actions.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
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FDA-CBER-2021-5683-1149413
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 7QUERY 5
Please clarify that bioburden sampling for the is taken at the
.
RESPONSE 5
In-process bioburden samples described in Table 3.2.S.2.3 -7. Process Flow for
are taken after the .
The final is sampled
.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
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FDA-CBER-2021-5683-1149414
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 8QUERY 6
Please provide the shipping validation for shipments of
Additionally , clarify if all shipments of will be temperature mo nitored
and shipped via validated shipping methods.
RESPONSE 6
The shipping validation assessed the for
shipment of from to
.
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FDA-CBER-2021-5683-1149415
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 9Analysis of the temperature monitor data for each of the shipments demonstrates that the
temperatures of the were adequately controlled and remained below the
when being transported in the shipper from to
All shipments of will be temperature monitored and shipped via
validated shipping methods.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
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FDA-CBER-2021-5683-1149416
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 10QUERY 7
Regarding the hold time study , please clarify what
media was tested, and how man y replicates were performed.
RESPONSE 7
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149417
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 11QUERY 8
Please include the acceptance criteria for
study (applicable to both
RESPONSE 8
The acceptance criteria (applicable to both
testing during
respectivel y.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149418
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 12QUERY 9
Please clarify how microbial control is verified during long term storage of the
samples should be taken at the end of storage and prior
to cleaning (applicable to both and
RESPONSE 9
Membranes are stored long term in
Therefore, samples cannot be taken and tested at
the end of storage to demonstrate microbial control.
In order to demonstrate that the membranes are ready for production following long term
storage, the following methodology is applied for both
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149419
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 13QUERY 10
Please clarify if any drug substance direct product contact items (e.g., single- use system,
tubing, gaskets, small par ts) 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, cy cle parameters used
during validation and in normal production operations, validation acceptan ce criteria, results
and any deviations.
RESPONSE 10
Literature References
None
SUPPORTING DOCUMENTATION
Note: The unlinked supporting documents will be submitted to BL A 125742 the week of 02
August 2021.
New or Replaced Supporting Documentation
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FDA-CBER-2021-5683-1149420
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 14
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FDA-CBER-2021-5683-1149421
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 15QUERY 11
Please provide the latest sterilization/depy rogenation revalidations for the stopper processors
used to support the
were both performed in 2019. This request is specific to Pfizer Puurs .
RESPONSE 11
The latest sterilization/depyrogenation revalidations are included in the updated Section
3.2.P.3.5 Stopper Depyrogenation and Sterilization [ Puurs and Section 3.2.P.3.5
Vial Depyrogenation [Puurs ].
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Section 3.2.P.3.5 Stopper Dep yrogenation and Sterilization [Puurs ] , replaced
Section 3.2.P.3.5 Vial Depy rogenation [Puurs ] , replaced
Previously submitted supporting documentati on
None
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FDA-CBER-2021-5683-1149422
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 16QUERY 12
Regarding Section 3.2.P.3.5 for the sterilizing filter, y ou state “for batch sizes in
markets where registered, a filter may also be used”. Please clarify if
this statement was intended for BLA 125742. If this is the case, please supply the filter
integrity test limits for the filter and the supporting validation report.
This request is applicable to both drug product sites of Pfizer Puurs and Kalamazoo.
RESPONSE 12
The applicant confirms that the referenced statement is not applicable to BLA 125742; as
described in Section 3.2.P.3.2 Batch Formula, the intended commercial batch size range for
BLA 125742 i s Section 3.2.P.3.5 Sterilizing Filter Membrane Validation –
has been updated to remove information related to the filter.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Section 3.2.P.3.5 Sterilizing Filter Membrane Validation – , replaced
Previously submitted supporting documentation
Section3.2.P.3.2 Batch Formula
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FDA-CBER-2021-5683-1149423
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 17QUERY 13
Regarding Section 3.2.P.3.5 for the sterilizing filter, the interim validation report
for the filter in contact with BNT162b2 performed b y the
issued 06 Dec 2020 was submitted. Please submit the final report from
and provide the supporting data for the integrit y test parameters provided for
. This req uest is applicable to both drug product sites of
Pfizer Puurs and Kalamazoo.
RESPONSE 13
The final validation report for the filter is included, please refer to INX100449287 .
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FDA-CBER-2021-5683-1149424
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 18
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FDA-CBER-2021-5683-1149425
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 19Literature References
None
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(b) (4)
FDA-CBER-2021-5683-1149426
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 20SUPPORTING DOCUMENTATI ON
New or Replaced Supporting Documentation
INX100449287, new
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
FDA-CBER-2021-5683-1149427
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 21QUERY 14
In Section 3.2.P.3.5 noting the shipping information, it is stated that y ou are currentl y
qualifying a capable of maintaining BNT162b2
at and the transport inside a ). Please
indicate if a ll shipments of BNT162b2 drug product transported via the
and in the are continuously temperature monitored to confirm that
the appropriate temperatures are maintained.
Please also provide an estimated time of com pletion for the ongoing shipping studies and the
procedures that support these shipping methods. This request is applicable to both drug
product sites of Pfizer Puurs and Kalamazoo.
RESPONSE 14
Pfizer confirms that all shipments of BNT162b2 drug product will be continuously
temperature monitored to confirm that the appropriate temperatures are maintained via
and in the .
Pfizer has not y et operationalized shipment at from either Pfizer Puurs or Pfizer
Kalamazoo and stu dies are still ongoing. Pfizer expects to complete qualification studies not
later than November 2021 and commits to providing results of these studies prior to
implementation.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149428
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 22QUERY 15
Please provide an update on the time frame for the completion of the microbial cleaning
validation of BNT162b2 equipment in
. This request is specific to Pfizer Puurs.
RESPONSE 15
The applicant confirms that Pfizer Puurs expects its microbial cleaning validation of
BNT162b2 equipment to be completed b y end of September 2021.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149429
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 23QUERY 16
Regarding the BNT162b2 major manufacturing equipment used at Pfizer Kalamazoo, the
Agency requests the following informatio n:
QUERY16a
The qualification summaries including dates of completion for all new direct product contact
equipment not included in the initial EUA submission relating to BNT162b2 manufacture.
RESPONSE 16a
The qualification of all new direct product contact equipment not included in the initial EUA
submission relating to BNT162b2 manufacture is summarized in Table 5.
Table 5.Major Manufacturing Equipment Qualification Status
Equipment Use Status Initial
QualificationLast
RequalificationIND 19736
Submission
Reference
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149430
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 24QUERY16b
It appears the . Please clarify the
and provide the study
protocol and summary , if available.
RESPONSE 16b
As described in Section 3.2.P.3.5 [Kalamazoo] (submitted in seq 0019
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
PPQProtocolfor COVID -19 VX
, new
Previously submitted supporting documentation
Section 3.2.P.3.5 [Kalamazoo]
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FDA-CBER-2021-5683-1149431
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 25QUERY16c
Please confirm that all product contact equipment is dedicated to BNT162b2 manufacture.
RESPONSE 16c
It is confirmed that all product contact equipment is dedicated to BNT162b2 manufacture.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
FDA-CBER-2021-5683-1149432
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 26QUERY16d
Please clarify if the dedicated product contact equipment used to manufacture BNT162b2 is
product dedicated or campaign dedicated. If campaign dedicated, please identify the nature of
the products with which it will be shared following the end of the campa ign.
RESPONSE 16d
The dedicated product contact equipment used to manufacture BNT162b2 is product
dedicated.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
FDA-CBER-2021-5683-1149433
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 27QUERY16e
Please explain if the drug product contact equipment for BNT162b2 is new equipment or existing equipment which have been
repurposed. If it has been repurposed, please identify the products used on the equipment previousl y and provide the changeov er
procedures for the equipment prior to dedication to BNT162b2.
RESPONSE 16e
The drug product contact equipment for BNT162b2 indicating if equipment is new or existing, identify ing products using the
equipment previously, and changeover procedure is summarized in Table 6. None of the previous products are considered potent
compounds.
Table 6.Drug Product Contact Equipment Summary
Equipment Location Equipment ID
NumberNew or Existing Previous Product (s) Changeover Procedure
Prior to BNT162b2
Dedication
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(b) (4)
FDA-CBER-2021-5683-1149434
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 28Table 6.Drug Product Contact Equipment Summary
Equipment Location Equipment ID
NumberNew or Existing Previous Product (s) Changeover Procedure
Prior to BNT162b2
Dedication
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(b) (4)
FDA-CBER-2021-5683-1149435
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 29Table 6.Drug Product Contact Equipment Summary
Equipment Location Equipment ID
NumberNew or Existing Previous Product (s) Changeover Procedure
Prior to BNT162b2
Dedication
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(b) (4)
FDA-CBER-2021-5683-1149436
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 30Table 6.Drug Product Contact Equipment Summary
Equipment Location Equipment ID
NumberNew or Existing Previous Product (s) Changeover Procedure
Prior to BNT162b2
Dedication
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
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FDA-CBER-2021-5683-1149437
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 31QUERY16f
Regarding the cleaning validation summary for the direct product -contact equipment, please
provide the rationale for not sampling bioburden or endotoxin for most of the equipment as
part of your cleaning validations. I n addition, please provide the necessary data that
demonstrates the proposed cleaning cy cles adequately remove bioburden and endotoxin from
all product -contact equipment .
RESPONSE 16f
New equipm ent is evaluated per site Standard Operating Procedure to determine the cleaning
validation requirements.
Table 7presentsbioburden and endotoxin data which support sthe equipment used in the
manufacture of BNT162b2 drug product .
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149438
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 26 Jul 2021 FDA queries –Comments regarding manufacturing and equipment
PFIZER CONFIDENTIAL
Page 32Table 7.Direct Product Contact Equipment Bioburden and Endotoxin Data
Equipment Indicator Results Limit
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197b2ad64\Approved\Approved On: 30-Jul-2021 21:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149439