43A STN 125742.0 4AUG21 LRP FU IR 2
Document text
ATTACHMENT 1 - Electronic Protocol Page 1
cc: 000000 _0/Lic #/ C or – B or –FC
Page 1 of y
Lot Number:
License Name of Product:
Reason For Submission
__ For Release
__ For Surveillance
__ For Licensing Action
Manufacturer Name: STN:
__ Corrected Protocol
Manufacturer Address:
Trade name:
Date of Manufacturing: 00/00/0000 Expiration Date: 00/00/0000
Label Strength: 00%
Source Material:
Processing Method:
Stabilizer:
Stabilizer:
Manufacturer / Lot Number
Other:
Reprocessing/Heating:
Fill Information
Filling Date: 00/00/0000
Location:
Total Volume: 000 mL Volume per Vial: 000 mL
Number of Vials filled: 0000 Number of Rejected Vials: 0000
Recommended Reconstitution Volume:
Storage Temperature:
All tests conducted on this lot are reported and pass specifications as required.
Signature: Date:
Title: Authorized Official
Electronic Protocol # - 202xxxxx.P0
FDA-CBER-2021-5683-1150203
ATTACHMENT 2 - eLRP Signature letter
Company Header
Food and Drug Administration Reason for Submission
Center for Biologics Evaluation and Research For Release
Sample Custodian For Surveillance
10903 New Hampshire Avenue For Licensing Action*
WO75 -G707 STN: ______________
Silver Spring, MD 20993-0002 For Corrected Letter
[DATE]
Subject: Electronic Protocol Signature Page
License No.: 0000 Company Name:____________________
[COMPANY NAME] hereby submits the following lot as an electronic submission by Electronic
Submissions Gateway (ESG). All test conducted on this lot are reported and pass specifications as required.
Proper name of product
Electronic Protocol
STN Lot Number Lot Type Filename
000000_0 000000000 C/B/FC 20100001.P0
Sample Status
Sample Not Required
Sample Submitted with Protocol
Sample Previous Submitted: [DATE]
Virus Verification
Software Name:
Company Name: Version:
Date of Definitions: DD/MM/YYYY Date of Scan: DD/MM/YYYY
I certify that the submission is virus- free.
The approximate file size of this submission is ___ KB/MB.
Comments:
Signature of Authorized Official
Printed Name and Title of Signatory Title
FDA-CBER-2021-5683-1150204
ATTACHMENT 3 - RNA content template
cc: STN / License No. –C or –B or –
FC Page x of y
Lot Number:
License Name of Product
RNA encapsulation and content test
Test date
Test method __________________
Sample/Control Specification Result
R2 for Standard A
R2 for Standard B
RNA (mg/mL)
Total RNA (mg/mL)
Encapsulated RNA (mg/mL)
Encapsulated RNA ( )
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150205
ATTACHMENT 4 – Identity Test
cc: STN / License No. –C or –B or –
FC Page x of y
Lot Number:
License Name of Product
Identity of encoded RNA sequence test
Test method __RT -PCR_________
Test date
Specification Identity confirmed Result __________________
Sample/Control Lot
number Replicate Ct value Acceptance
criteria Pass/Fail
DP Sample
1
2
3
Positive PCR Control
1
2
3
Positive
Control
1
2
3
Negative PCR Control
1
2
3
Negative
Control 1
2
3
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150206
ATTACHMENT 5 – In Vitro Expression
cc: STN / License No. –C or –B or –
FC Page x of y
Lot Number:
License Name of Product
In Vitro Expression Assay
Test date
Test method __________________
Specification cells positive
Lot number
Positive Control lot number
% cell viability
Average Number of Cells Counted for Sample
Test Result (% positive cells)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150207
ATTACHMENT 6 - Limulus Amebocyte Lysate Test template
cc: STN / License No. –C or –B or –
FC Page x of y
Lot Number:
License Name of Product
Limulus Amebocyte Lysate Test
(b) (4)
FDA-CBER-2021-5683-1150208