SOP for Preparation and Review of Performance Reports for Efficacy Testing Date Revised: 04-28-11


US Environmental Protection Agency
Office of Pesticide Programs
SOP for Preparation and Review of
Performance Reports for Efficacy Testing
Date Revised: 04-28-11

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SOP No. ADM-01-04
Date Revised 04-28-11
Page 1 of 8
EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD
Standard Operating Procedures
for
Preparation and Review of Performance Reports for Efficacy Testing
SOP Number: ADM-01-04
Date Revised: 04-28-11
Initiated By:		Date:
Print Name:	
Technical Review:	Date: / /
Print Name:
Technical Staff
QA Review:		Date:
Print Name:	
QA Officer
Approved By:		Date: / /
Print Name:	
Branch Chief
Effective Date: / /
Controlled Copy No.:
Withdrawn By:
Date: / /

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SOP No. ADM-01-04
Date Revised 04-28-11
Page 2 of 8
TABLE OF CONTENTS
Contents	Page Number
I.0	SCOPE AND APPLICATION	3
2.0 DEFINITIONS	3
3.0 HEALTH AND SAFETY	3
4.0 CAUTIONS	3
5.0 INTERFERENCES	3
6.0 PERSONNEL QUALIFICATIONS	3
7.0 SPECIAL APPARATUS AND MATERIALS	4
8.0 INSTRUMENT OR METHOD CALIBRATION	4
9.0 SAMPLE HANDLING AND STORAGE	4
10.0 PROCEDURE AND ANALYSIS	4
II.0	DATA ANALYSIS/CALCULATIONS	6
12.0 DATA MANAGEMENT/RECORDS MANAGEMENT	6
13 .0 QUALITY CONTROL	6
14.0 NONCONFORMANCE AND CORRECTIVE ACTION	6
15.0 REFERENCES	6
16.0 FORMS AND DATA SHEETS	6

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SOP No. ADM-01-04
Date Revised 04-28-11
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1.0 SCOPE AND APPLICATION: This protocol describes the procedures for the
preparation and review of Performance Reports for products tested for efficacy against
one or more microorganisms.
2.0 DEFINITIONS:
2.1	Performance Report = A report documenting the efficacy test on a product as
tested by the prescribed method. The final performance report contains
information referred to in Section 10.2.1.
2.2	ATP = Antimicrobial Testing Program
2.3	BR As = Bi ol ogi cal Report of Analy si s
2.4	COC = Chain of Custody
2.5	GLP = Good Laboratory Practice Standards
2.6	MLB = Microbiology Laboratory Branch
2.7	OPP = Office of Pesticide Programs
2.8	AD = Antimicrobials Division
2.9	Quality Assurance (QA) Statement = A statement issued by the Quality
Assurance Officer (QAO) of Microbiology Laboratory Branch that identifies the
quality assurance audit trail and review of the report.
3.0 HEALTH AND SAFETY: None
4.0 CAUTIONS: None
5.0 INTERFERENCES:
5.1 Incomplete paperwork and documentation can impede the report process and may
impact further regulatory and enforcement action.
6.0 PERSONNEL QUALIFICATIONS:
6.1 Personnel responsible for the preparation and review of final performance reports
are required to be knowledgeable of the procedures in this SOP.

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SOP No. ADM-01-04
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7.0 SPECIAL APPARATUS AND MATERIALS: None
8.0 INSTRUMENT OR METHOD CALIBRATION: None
9.0 SAMPLE HANDLING AND STORAGE: None
10.0 PROCEDURE AND ANALYSIS:
10.1	Summary: A Performance Report consists of information relevant to the testing
of a product and may include documents such as the study protocol, data sheets,
sample labels, chain of custody documentation, as well as documents required
under Good Laboratory Practice Standards such as the GLP Statement and
Quality Assurance audit information. The test report and Biological Report of
Analysis forms are sent with a transmittal memo, which summarizes the testing
history and is signed by the Branch Chief.
10.2	Reporting Format of a Typical Performance Report
10.2.1 The Performance Report is compiled and finalized within 4 weeks
after all data collection is completed for the product analysis. The
Performance Report, which is assembled sequentially, consists of, but
is not limited to, the following:
Quality Assurance Unit Statement
Title Page
GLP Statement (original signatures)
Study Protocol and Attachments
Test Coordinator and Analyst Signature Page (original signatures)
Data Summary Sheets
Photocopies of Test Data Sheets (Test Information Sheet, Results
Sheet, Confirmation Sheets, Carrier Count Data and Spreadsheet,
Vitek printouts, and Neutralization Confirmation Assays Sheets
[when applicable])
Photocopies of the Chain of Custody (Documentation for samples
tested)
Photocopies or photographs of product label on sample container.
Refer to Attachment A for general report format.
10.2.2 Accompanying the Performance Report is (are) the completed
Biological Report(s) of Analysis(es) (EPA Form 8510-14).

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SOP No. ADM-01-04
Date Revised 04-28-11
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10.3	Revi ew of Draft Report
10.3.1	The product Test Coordinator or assigned Report Coordinator
assembles the Draft Report in a binder and checks it for completeness.
A completed BRA without analyst initials is submitted along with the
Draft Report and BRA to another analyst for peer review.
10.3.2	A Report Preparation and Quality Control Checklist (see Attachment
B) is filled out and a copy sent with the Performance Report to the
Study Director (SD) or designee for review.
10.3.3	Once the peer review is completed, the Study Director or designee
reviews the Draft Report for errors and completeness, and returns the
Draft Report to the Coordinator who incorporates any
corrections/changes. Alternatively, if there are only minor comments,
the Study Director may submit the Draft Report directly to the QAU.
10.4	Quality Assurance Review of Draft Report
10.4.1	After completion of the Draft Report and all subsequent
corrections/changes, the report is submitted to the QAU.
10.4.2	The QAU reviews the Draft Report for completeness and determines
whether additional revisions/corrections are necessary.
10.4.3	If errors are noted by the QAU, the QAU either submits a memo
outlining the revisions/corrections necessary for the Report or makes
notations in the Draft Report and returns it to the Coordinator.
10.4.4	The Coordinator ensures all required revisions/corrections are
completed by the appropriate analyst(s) and submits the final report
and signed BRA to the QAU for final review. The final report is page
stamped.
10.4.5	The QAO verifies that all corrections or required revisions have been
made and issues the QA statement.
10.4.6	The coordinator submits the original page stamped report and one
bound copy along with the signed BRA and a draft transmittal memo
to the Branch Chief for signature.
10.4.7
The Branch Chief reviews the Final Performance Report and adds

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SOP No. ADM-01-04
Date Revised 04-28-11
Page 6 of 8
signatures and date to the BRA(s).
10.4.8 The Final Performance Report with original signatures and signed
BRA (original signatures) along with a transmittal memo are sent to
the Antimicrobials Division by the Branch Chief or designee. A
"Record of Customer Feedback" form is sent as well to solicit
feedback on the quality of the laboratory services. (One copy of the
Final Report and BRA(s), and original Test Data Sheets, and original
Study Protocols and Attachments are archived in MLB's archive
room). The transmittal memo, BRA and full report are scanned and
stored on the G share files.
11.0 DATA ANALYSIS/CALCULATIONS: None
12.0 DATA MANAGEMENT/RECORDS MANAGEMENT:
12.1 Completed reports, original Test Data Sheets, and original Study Protocols and
Attachments are archived in secured file cabinets in room D217. Only authorized
personnel have access to the secured files. Archived data are subject to OPP's
official retention schedule contained in MLB's SOP ADM-03, Records and
Archive.
13.0 QUALITY CONTROL:
13.1	The OPP Microbiology Laboratory conforms to 40 CFR Part 160, Good
Laboratory Practice Standards. Appropriate quality control measures are
integrated into each SOP.
13.2	Studies are tracked in the Master Schedule which is maintained electronically and
archived as per SOP QA-04, Master Schedule Preparation.
14.0 NONCONFORMANCE AND CORRECTIVE ACTION:
14.1 Any nonconformance will be documented and appropriate corrective action(s)
will be implemented.
15.0 REFERENCES: None.
16.0 FORMS AND DATA SHEETS:
16.1	Attachment A: Report Format - Hospital/General Disinfectant Claims
16.2	Attachment B: Report Preparation and Quality Control Checklist

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SOP No. ADM-01-04
Date Revised 04-28-11
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Attachment A
General Guidance
Report Format - Hospital/General Disinfectant Claims
Develop a report as described below for ALL product tests (passing and failing). Please put the documents in
the order noted on this list. The BRA and draft transmittal are independent of the body of the report but should
be submitted with the report. Please use the "Report Preparation and Quality Control Checklist" as a guide. A
report may have additional components depending on the method and the outcome of the test.
Front section: (no tab required)
Title Page
GLP Statement
QA Statement
Study Protocol
Test Parameters (signed by AD)
Analyst Signature Page (for the study)
For each organism - tab separately (label the tab by organism)
Data Summary Sheet
Test Information Sheet
Test Results Sheet
Confirmation Sheet
Vitek Printouts
Carrier Count Data Sheet
Carrier Count Spreadsheet
Neutralization Results Sheet (if conducted)
Chain of Custody Documentation (label tab as "Chain of Custody")
Shipping and receiving record (optional: package receiving log)
History of Official Sample
Laboratory COC form
Seal Log
Correspondence from the company
Label copies
In addition the following documentation should be submitted for QA review in a separate folder. Once
the report has been reviewed the documentation noted below can be placed under a separate tab in the
lab copy only of the report as "Supporting Documentation".
Organism tracking log
Time Recording Sheets (carrier transfer, carrier inoculation)
Media sterility and performance summary sheet
Gram Stain Worksheet (if used)
Serial dilution/plating form
Equipment form
Any unique information specific to the product (prep forms for unusual neutralizes, emails about soil
ingredients etc.)

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SOP No. ADM-01-04
Date Revised 04-28-11
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Attachment B
Report Preparation and Quality Control Checklist
OPP Microbiology Laboratory
Protocol #: 	 Test(s) Performed:
Product Name: EPA Reg. No.:
Sample No(s).: 	
Report Paperwork
Compiled
By/Date:
Reviewed by Study
Director/Date
Revisions Made
By/Date:
Reviewed by
QAO/Datc
Revisions Made
By/Date:
Final Report
Reviewed
bv/Dalc:
Title Page






GLP Statement






Study Protocol/Attachments






Test Coordinator Signature Page






Data Summary Shccl(s)






Test Data Sheets






Carrier Count Spreadsheet






Inspector s COC Documentation






Lab s COC Documentation






Product Sample Labcl(s)






BRA(s)






Draft Transmittal Memo






Media/Reagents Prep Sheets (check only)






Other: (organism tracking)






Apply N/A (not applicable) where necessary.

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