Providing Lot Release Protocol 
Submissions to the Center for 
Biologics Evaluation and Research 
(CBER) in Electronic Format
 
 
 
Guidance for Industry 
 
 
 
 
 
This guidance is for immediate implementation. 
 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(4)(i).  Submit one set of either electronic or written comments on this 
guidance at any time.  Submit electronic comments to https://www.regulations.gov/.  Submit 
written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  You should identify all comments with 
docket number FDA-1998-D-0095 (formerly docket number 1998D-0315).   
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, 
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010 or email at ocod@fda.hhs.gov, 
or from the Internet at 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guid
ances/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
February 2019 
 
  Contains Nonbinding Recommendations   
Table of Contents 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 2 
A.  Format for Electronic Lot Release Protocol Submissions................................. 3 
1.  Hypertext Links and Bookmarks ...................................................................... 3 
2.  Electronic Lot Release Protocol Signature Letter ............................................. 4 
3.  Naming the Electronic Lot Release Protocol File ............................................. 4 
B.  Electronic Lot Release Protocol Submissions Through FDAs Electronic 
Submissions Gateway ........................................................................................... 4 
1.  Preparatory Steps for Using the ESG................................................................ 5 
2.  Procedures Following the Completion of the Preparatory Steps ...................... 6 
3.  Help and Information ........................................................................................ 7 
C.  Electronic Lot Release Protocol Submissions on CD-ROM ............................. 8 
1.  Labeling the CD-ROM ..................................................................................... 8 
2.  Packaging and Shipping .................................................................................... 8 
3.  Delivery Address .............................................................................................. 9 
D.  Feedback on Your Electronic Lot Release Protocol Submission ...................... 9 
E.  Shipping Samples to FDA When Using the ESG to Submit the Associated Lot 
Release Protocols ................................................................................................... 9 
APPENDIX 1:  EXAMPLE OF A TABLE OF CONTENTS WITH BOOKMARKS FOR 
AN ELECTRONIC LOT RELEASE PROTOCOL ................................................................ 10 
APPENDIX 2:  EXAMPLES OF CD-ROM LABELS ......................................................... 11 
APPENDIX 3:  CHECKLIST PRIOR TO SUBMITTING AN ELECTRONIC LOT 
RELEASE PROTOCOL ............................................................................................................ 12 
   
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Providing Lot Release Protocol Submissions to the Center for 
Biologics Evaluation and Research (CBER) in Electronic Format 
 
 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  INTRODUCTION 
 
We, the Center for Biologics Evaluation and Research (CBER), within the U.S. Food and Drug 
Administration (FDA, the agency, or we), are issuing this guidance under Title 21 of the Code of 
Federal Regulations (CFR) 601.14(a) to assist you, manufacturers of biological products 
regulated by CBER,1 in submitting lot release protocols in electronic format to CBERs Product 
Release Branch, within the Office of Compliance and Biologics Quality (OCBQ).  This guidance 
updates and supersedes the similarly named guidance, Guidance for Industry, Providing 
Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in 
Electronic Format - Lot Release Protocols, dated November 2007 (2007 guidance).  We are 
updating this guidance to include the submission of electronic lot release protocols through the 
FDAs Electronic Submissions Gateway (ESG).2  
 
In the Federal Register of December 8, 1995 (60 FR 63048),3 we announced that we no longer 
require routine lot-by-lot release for specified categories of biological products subject to 
licensure, previously referred to as well-characterized therapeutic recombinant DNA-derived and 
monoclonal antibody biotechnology products (see 21 CFR 601.2(c)).  This guidance is not 
intended to modify that document. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the FDAs current thinking on a topic and should be 
viewed only as recommendations unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDAs guidance means that something is suggested or 
recommended but not required. 
                                                 
1 Although most lot release protocols and products that are submitted for the lot release program are regulated by 
CBER, the program also receives a small number of lot release protocols for products that are regulated by the 
Center for Drug Evaluation and Research (CDER).   
2 For general information about regulatory submissions in electronic format for biological products, see 
https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/ucm163685.htm. 
3 Federal Register notice entitled Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized 
Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products. 
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II.  BACKGROUND 
 
The ESG is an agency-wide solution for accepting electronic regulatory submissions.  The ESG 
enables the secure submission of premarket and postmarket regulatory information to FDA for 
review.  It is the central transmission point for sending secure information electronically to the 
agency.  Within that context, the ESG is a conduit along which submissions travel to reach the 
proper FDA Center or Office. 
 
Lot release is a system that permits FDA to verify product quality through protocol review and 
sample testing of many biological products that we regulate.  In accordance with 21 CFR 
610.2(a), CBER may require you to submit for CBER review and confirmatory testing samples 
of any lot of any licensed product, together with the protocols showing results of applicable tests 
when deemed necessary for the safety, purity, or potency of the product.  
 
 
III.  DISCUSSION 
 
Submission of your lot release protocol submissions, consistent with lot release requirements 
applicable to your product, in an electronic format that is readily accessible will facilitate our 
review of your submission. 
 
FDA has encouraged applicants to submit lot release protocols electronically through the ESG 
since 2009.  This guidance is being updated to provide information on using the ESG.  It 
includes a high-level description of the procedures that are necessary for manufacturers to use 
the ESG to submit lot release protocols to CBER; however, we also refer manufacturers to 
various website links for more detailed information on using the ESG for this purpose.  The 
information available on our website is updated periodically.          
 
Pursuant to 21 CFR 11.2(b)(2), FDA has identified lot release protocols as one of several 
submission types described in Public Docket 1992S-0251 that the agency accepts in electronic 
format.  We encourage the use of FDAs ESG for submitting electronic lot release protocols to 
CBER because it facilitates our ability to receive and review these submissions.  If 
manufacturers are not able to provide these submissions to us using the ESG, manufacturers may 
use other means to submit their lot release protocols to the agency, such as mailing a compact 
disc read-only memory (CD-ROM4).5  This guidance is intended to provide you with  
 
 
 
 
 
 
                                                 
4 CBERs Product Release Branch accepts lot release protocol submissions on digital video disc or digital versatile 
disc (DVDs) in addition to CD-ROMs.  The submission process for DVDs is identical to the submission process for 
CD-ROMs that is described in this guidance. 
5 We discourage the submission of lot release protocols in paper format, but we continue to accept these submissions 
when firms are not able to submit their lot release protocols electronically.  
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  Contains Nonbinding Recommendations   
recommendations for submitting lot release protocols showing results of applicable tests in an 
electronic format, as provided in 21 CFR Part 11.6   
 
A secure email account should be established with FDA to protect proprietary and confidential 
information and to facilitate communication.  A secure email address allows for encrypted 
exchange between the manufacturer and the agency, for example, about your electronic lot 
release protocol.7  CBER-generated email regulatory communication will only be sent via secure 
email.8  For information on how to establish a secure email account with CBER, you may 
contact the agency at SecureEmail@fda.hhs.gov.  
 
A.  Format for Electronic Lot Release Protocol Submissions 
 
Manufacturers should submit their lot release protocols in a portable document format 
(PDF) file when transmitting electronically to CBERs Product Release Branch.  We 
request this format when submitting electronically through the ESG as well as when 
submitting electronically by CD-ROM.  The lot release protocol PDF file should be 
placed in an electronic folder, and the folder name should be the 6-digit submission 
tracking number (STN).9  Manufacturers who are currently submitting their lot release 
protocols to CBER using a paper format should only need minor modifications for the 
conversion to PDF.  The PDF version should be full-text searchable and not simply a 
static scan of the entire paper protocol.  We recommend that you do not use the security 
option and passwords for the submission, as these could make it difficult for us to access 
your data.  You may send an email message to the Product Release Branch at 
CBERLotRelease@fda.hhs.gov to receive a lot release protocol template. 
 
1.  Hypertext Links and Bookmarks 
 
Lot release protocols vary in length, depending on the specific content.  We 
recommend that you use functional bookmarks or a hypertext linked Table of 
Contents to facilitate navigating the protocol, especially for larger ones.  An 
example of a Table of Contents with bookmarks is provided in Appendix 1 at the 
end of this guidance. 
 
 
                                                 
6 FDA issued a Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and 
Application, dated August 2003 (September 5, 2003, 68 FR 52779), describing a policy of enforcement discretion 
relating to certain Part 11 requirements (see 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm).  We update guidance periodically.  To 
ensure that you have the most recent version of a guidance, check the FDA Drugs guidance webpage at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.   
7 Electronic lot release protocols should not be emailed to the agency.   
8 See FDA SOPP 8119: Use of Email For Regulatory Communications, Version 3, dated October 1, 2018, at 
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresS
OPPs/UCM585760.pdf. 
9 For allergenic products that use the second level STN to identify the product, you should use the primary and 
secondary level numbers, separated by an underscore, as the folder name. 
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  Contains Nonbinding Recommendations   
2.  Electronic Lot Release Protocol Signature Letter 
 
For purpose of signing the lot release protocol in PDF, you should use the 
electronic lot release protocol (e-LRP) Signature Letter, which includes 
information about your company and the lot release protocol that you are 
submitting.10  The e-LRP Signature Letter should be included as the first page of 
the lot release protocol PDF file.11  You may send an email message to the 
Product Release Branch at CBERLotRelease@fda.hhs.gov to receive information 
on the latest e-LRP Signature Letter template to use. 
 
3.  Naming the Electronic Lot Release Protocol File 
 
The e-LRP, in PDF, must be assigned a unique filename for each product lot.  The 
filename is composed of alphanumeric characters.  You should not use any 
special characters in the filename.  The first four numbers represent the year of 
the submission (e.g., 2018).  The next four numbers represent the sequential lot 
submitted for that year (e.g., 0001, 0002, 0003, etc.), and these 8 numbers are 
followed by a dot.  The final two to three alphanumeric characters represent the 
type of submission (.P0 (zero) specifies an original protocol, and .PC specifies a 
corrected protocol).  Thus, 20180003.P0 represents the original protocol for the 
third lot submitted in the year 2018.     
 
A corrected lot release protocol is a submission to correct minor clerical or 
transcription errors or to clarify lot release information in response to questions by 
FDA.  For submissions under a corrected lot release protocol, designate each 
corrected protocol using .PC, followed by the correction number (i.e., .PC1 
represents the first corrected protocol, .PC2 represents the second corrected 
protocol, etc.).  Thus, 20180003.PC1 represents the first correction of the original 
protocol for the third lot submitted in the year 2018. 
 
B.  Electronic Lot Release Protocol Submissions Through FDAs Electronic 
Submissions Gateway 
 
Currently, our preferred method of transmitting lot release protocols is through FDAs 
ESG.  The FDAs ESG provides a single point of entry for receiving and processing all 
electronic submissions in a highly secure environment.  It complies with secure 
Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for 
secure communication.  The electronic submission process through the ESG encompasses 
the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a 
receiving FDA Center or Office) of an electronic submission.   
 
Manufacturers have two options for sending submissions through the ESG to the agency: 
WebTrader or Applicability Statement 2 (AS2). 
                                                 
10 The authorized official noted on the first page of the electronic lot release protocol should be the same person who 
signs the e-LRP Signature Letter.   
11 The signed e-LRP Signature Letter portion of the PDF file does not need to be text searchable. 
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  Contains Nonbinding Recommendations   
WebTrader is a Web interface designed for low volume submitters and is likely the most 
appropriate method for manufacturers who want to submit lot release protocols to the 
agency.  This web-based interface, which involves installing software on the submitters 
computer, is used to send documents and receive receipts and acknowledgments from 
FDA.  The WebTrader application makes communication with FDA simple, cost-
effective, and time-independent.  WebTrader requires each user from an industry partner 
to register for his or her own unique WebTrader account.  
 
AS2 is a system-to-system connection (also referred to as a server-to-server or 
gateway-to-gateway connection) to exchange information with FDA.  AS2 requires a 
gateway software implementation on the submitters end, requiring a server(s) and 
software procurement and configuration.  AS2 provides an automated connection to FDA 
for submissions, receipts, and acknowledgments.  System-to-system communication 
requires one user from an organization to register for the organizational account.   
 
The ESG User Guide, available on our website,12 provides manufacturers with an 
overview of the ESG registration process, the preparatory steps that are necessary for 
establishing an ESG account, and the specific steps that are necessary for establishing a 
WebTrader (Web interface) ESG account,13 in addition to other resources.  The User 
Guide explains how to send documents through the ESG, including the creation of test 
and production accounts.  We recommend that manufacturers refer to the ESG User 
Guide and the additional links that are on our ESG webpage for current and complete 
information on how to use the ESG. 14   
 
There are several preparatory steps that are needed prior to beginning the ESG 
registration process.  In this guidance, we provide a high-level overview of these 
preparatory steps.  Considerations for each preparatory step are covered in more detail in 
the ESG User Guide.  
 
1.  Preparatory Steps for Using the ESG 
 
a.  Send an Email Message to the ESG Help Desk 
 
Send an email message to ESGHelpDesk@fda.hhs.gov, indicating that 
you would like to register for an ESG account. 
 
b.  Submit a Letter of Non-Repudiation Agreement 
 
The non-repudiation agreement allows FDA to receive electronically 
signed submissions in compliance with 21 CFR 11.100. 
 
 
                                                 
12 See https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm334359.htm for the ESG User Guide. 
13 The ESG User Guide also includes information for establishing an AS2 ESG account. 
14 See https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm for general information on the 
ESG. 
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  Contains Nonbinding Recommendations   
c.  Obtain a Digital Certificate 
 
Digital certificates ensure private and secure submission of electronic 
documents.  The digital certificate binds together the owners name and a 
pair of electronic keys (a public key and a private key) that can be used to 
encrypt and sign documents. 
 
d.  Understand the Submission Guidelines, Including File Naming 
Conventions 
 
The guidelines for preparing lot release protocol submissions are 
described in section III.A. of this guidance. 
 
e.  Determine the Submission Method 
 
Manufacturers who want to submit lot release protocols can use the ESG 
Web Interface by creating a WebTrader account or using an AS2 gateway-
to-gateway account.  WebTrader is designed for low-volume submitters 
and is likely the most appropriate method for manufacturers who want to 
submit lot release protocols to the agency. 
 
f.  Review and Ensure that the Connection Requirements for the 
Selected Submission Method Are Met 
 
The ESG User Guide lists the requirements for each method, including 
Web browsers, software, disk space, and connection speed. 
 
2.  Procedures Following the Completion of the Preparatory Steps 
 
After completing the preparatory steps, manufacturers may consult the ESG User 
Guide for the steps that are necessary to submit lot release protocols through the 
ESG by establishing a WebTrader account (Chapter 4), or an AS2 connection 
(Chapter 5).  The following steps are necessary to establish an ESG production 
account for submitting your lot release protocols to CBER through the ESG:15  
 
a.  Obtain Access to the Electronic Submissions Gateway 
 
The ESG User Guide explains how to set up a test account and a 
production account.  Once a test account is approved and set up for a 
WebTrader account, a profile will need to be established for each 
individual who will need access.  For example, if more than one person 
will be submitting electronic lot release protocols from the same 
                                                 
15 We provide a high-level summary of the steps that are necessary to establish an ESG production account in this 
guidance.  We recommend that manufacturers consult the ESG User Guide and the additional information that we 
have on our ESG webpage for a more detailed description. 
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  Contains Nonbinding Recommendations   
manufacturing facility, each person will need to create his or her own 
profile and send a test submission. 
 
b.  Send a Test Submission Through the ESG  
 
To receive an ESG production account, which permits manufacturers to 
submit lot release protocols through the ESG, manufacturers should first 
successfully submit a lot release protocol test submission that is formatted 
as described in section III.A. of this guidance.  You may use a previously 
submitted lot release protocol in PDF as your test submission.    
 
Lot release protocol PDF files should be placed in an electronic folder 
prior to sending them through the ESG, and the folder name should be the 
6-digit STN.  Placing the lot release protocol PDF file in a folder prior to 
sending it through the ESG helps to ensure that the filename is maintained.   
 
For WebTrader accounts, each individual who establishes a profile should 
send one test submission through the ESG.  The same test submission may 
be used by multiple individuals. 
 
c.  ESG Notification 
 
The ESG system will immediately notify you when your test submission 
has been successfully received through the ESG.  If you do not receive a 
successful transmission notification, contact the ESG Help Desk at 
ESGHelpDesk@fda.hhs.gov and inform them that you have not received a 
communication indicating that the transmission was received. 
 
d.  Feedback on the ESG Test Submission 
 
Manufacturers should send an email message to CBERs Product Release 
Branch at CBERLotRelease@fda.hhs.gov after sending the test 
submission to ensure that the Branch has received it.  When the Product 
Release Branch successfully receives your test submission and confirms 
that it is in the proper format, you will be notified by ESG Help Desk 
personnel that your access has been upgraded to an ESG production 
account.  You may then proceed to send your lot release protocols to 
CBER through the ESG. 
 
3.  Help and Information 
 
If you need assistance with establishing an ESG account or using your ESG 
production account, you may send an email message to FDAs ESG Help Desk at 
ESGHelpDesk@fda.hhs.gov.   
 
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  Contains Nonbinding Recommendations   
If you have questions for CBER, regarding submission standards and formatting, 
you may send an email message to CBER Electronic Submissions (ESUB) at 
esubprep@fda.hhs.gov. 
 
C.  Electronic Lot Release Protocol Submissions on CD-ROM 
 
If manufacturers are not able to submit lot release protocol files through the ESG, you 
may submit your electronic files on CD-ROM as an alternative to our preferred method.  
Creation and file naming of an electronic lot release protocol in a PDF file for submitting 
on a CD-ROM involves the same procedures as those for creating an electronic lot 
release protocol for submitting through the ESG (see section III.A. of this guidance). 
 
1.  Labeling the CD-ROM 
 
You should label your CD-ROM and CD-ROM case to identify your submission 
with the following information: 
 
a.  Manufacturer name; 
 
b.  Date of submission in the format of DD-MMM-YYYY, with DD 
and YYYY being numerical and MMM being the first three letters 
of the month (e.g., AUG for August); 
 
c.  STN, license number, and type of lot (FC for final container, B 
for bulk, C for Concentrated); 
 
d.  Electronic lot release protocol filename(s); and 
 
e.  Lot number(s). 
 
We provide examples of labeled CD-ROMs and their corresponding CD-ROM 
cases in Appendix 2 at the end of this guidance.  We recommend that you label 
your CD-ROM in a manner that does not interfere with data retrieval. 
 
2.  Packaging and Shipping 
 
CD-ROMs should be packaged carefully to ensure that they arrive in a usable 
condition.  CD-ROM cases are less vulnerable when shipped in envelopes with 
bubble-type protective material or stiff backing.  Mailing envelopes padded with 
paper material, only, typically do not provide adequate protection for shipping 
CD-ROMs. 
 
 
 
 
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  Contains Nonbinding Recommendations   
3.  Delivery Address 
 
CD-ROMs should be sent to the address below.  If you are sending lot release 
samples along with your CD-ROM, you must use a courier service (see 21 CFR 
600.2(c)).   
 
Food and Drug Administration  
Center for Biologics Evaluation and Research  
Sample Custodian 
10903 New Hampshire Avenue 
WO75-G707 
Silver Spring, MD 20993-0002 
 
D.  Feedback on Your Electronic Lot Release Protocol Submission 
 
A checklist to help ensure that your electronic lot release protocol is in the proper format 
prior to submitting it to CBER is provided in Appendix 3 at the end of this guidance.  
Once your lot release protocol in electronic format has been received and reviewed by the 
Product Release Branch, the Branch staff will contact you if your submission is not in the 
proper format.  Modifications or resubmissions may be needed, particularly for your 
initial electronic lot release protocol submission, and we will work with you to ensure an 
adequate submission. 
 
E.  Shipping Samples to FDA When Using the ESG to Submit the Associated Lot 
Release Protocols 
 
Often lot samples are submitted well before the lot release protocol, while the lot is still 
in release testing by the manufacturer, to help facilitate sample processing and CBER 
concurrent testing.  If you submit lot samples while release testing is ongoing, you should 
include a concurrent testing letter along with your samples.  You may send an email 
message to the Product Release Branch at CBERLotRelease@fda.hhs.gov to receive the 
latest template for the appropriate Concurrent Testing Letter (the Concurrent Testing 
Letter for general use or the Concurrent Testing Letter for test kits). 
 
 
   
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  Contains Nonbinding Recommendations   
APPENDIX 1: EXAMPLE OF A TABLE OF CONTENTS WITH BOOKMARKS FOR 
AN ELECTRONIC LOT RELEASE PROTOCOL 
 
1. STN/License No./Type of Lot [Bulk, Final Container, Concentrated] 
2. Lot Number  
3. Proper Name of Product  
4. Firm Name and Address 
5. Reason for Submission 
6. Test Result Pass Statement 
7. Signature Block 
8. Electronic Protocol: 20180001.P0 
9. Test Results  
a. Potency 
b. Specific Activity 
c. pH 
d. Moisture 
e. Total Protein 
f.  Solubility 
g. Sterility  
i.  Sterility Bulk 
ii. Sterility Final Container  
h. Purity 
i.  Limulus Amoebocyte Lysate (LAL) 
ii. Pyrogen 
i.  Laser Densitometer (LD) Scan  
i.  LD Scan 
ii. LD Scan Reference  
   
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APPENDIX 2: EXAMPLES OF CD-ROM LABELS 
 
A) Single Product Submission      B) Multiple Product Submission 
 
   
ABC Pharmaceuticals   ABC Pharmaceuticals 
DD-MMM-YYYY  DD-MMM-YYYY  
123456_0 / 0999-B   License #: 0999  
       123456_0-B          123457_0-FC 
       
 
File Name               File Name 
 
20180095.P0             20180098.P0 
 
20180096.P0             20180099.P0 
 
 
 
123456_0-FC 
File Name  
File Name 
20180084.PC1 
20180094.PC1, 20180097.P0 
20180085.P0-20180089.P0 
 
 
 
   
 
 
C) CD Case for Disc A                               D) CD Case for Disc B 
0999 ABC Pharmaceuticals   0999 ABC Pharmaceuticals 
DD-MMM-YYYY  DD-MMM-YYYY 
123456_0-B 
STN   Lot #  Filename 
Lot #  Filename 
 
8799795A  20180084.PC1  123456_0-B   8899989B  20180095.P0 
8799989B  20180085.P0  123456_0-B   8899995A  20180096.P0 
9567428C  20180087.P0  123456_0-FC   9567415B  20180094.PC1 
9567428D  20180088.P0  123456_0-FC   9567418C  20180097.P0 
9567429K  20189989.P0  123457_0-FC   9567418D  20180098.P0 
123457_0-FC   9567419K  20180099.P0 
 
 
 
   
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APPENDIX 3: CHECKLIST PRIOR TO SUBMITTING AN ELECTRONIC LOT 
RELEASE PROTOCOL 
 
  Confirm that the e-LRP Signature Letter is the first page of the electronic lot release protocol 
PDF file 
  Confirm that the authorized official noted on the first page of the electronic lot release 
protocol is the same person who signs the e-LRP Signature Letter    
  Confirm that the file name for the electronic lot release protocol is in the correct format (see 
section III.A.3. of this guidance) 
  Confirm that the folder name is correct (see section III.A. of this guidance) 
  Confirm that the reason for submission section is on the first page of the electronic lot 
release protocol and on the e-LRP Signature Letter 
  Confirm that the appropriate box for the reason for submission is marked  
  Confirm that your entire electronic lot release protocol is text-searchable  
  Confirm that your electronic lot release protocol file is virus-free  
 
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