Standard Operating Procedure for Preparation and Review of Product Performance Reports SOP Number: ADM-01-05 Date Revised: 04-22-14


US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Microbiology Laboratory
Environmental Science Center, Ft. Meade, MD
Standard Operating Procedure for
Preparation and Review of Product Performance Reports
SOP Number: ADM-01-05
Date Revised: 04-22-14

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SOP No. ADM-01-05
Date Revised 04-22-14
Page 1 of 7
SOP Number
ADM-01-05
Title
Preparation and Review of Product Performance Reports
Scope
This protocol describes the procedures for the preparation and
review of Performance Reports for disinfectant products tested for
efficacy against one or more microorganisms.
Application
This SOP is applicable for preparation of all performance reports
generated by Microbiology Laboratory Branch (MLB) under the
Antimicrobial Testing Program (ATP).


Approval Date
SOP Developer:

Print Name:
SOP Reviewer

Print Name:
Quality Assurance Unit

Print Name:
Branch Chief

Print Name:


Date SOP issued:

Controlled copy
number:

Date SOP withdrawn:

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SOP No. ADM-01-05
Date Revised 04-22-14
Page 2 of 7
TABLE OF CONTENTS
Contents	Page Number
1.
DEFINITIONS
3
2.
HEALTH AND SAFETY
3
3.
PERSONNEL QUALIFICATIONS AND TRAINING
3
4.
INSTRUMENT CALIBRATION
3
5.
SAMPLE HANDLING AND STORAGE
3
6.
QUALITY CONTROL
3
7.
INTERFERENCES
3
8. NON-CONFORMING DATA
3
9.
DATA MANAGEMENT
3
10.
CAUTIONS
3
11.
SPECIAL APPARATUS AND MATERIALS
3
12.
PROCEDURE AND ANALYSIS
4
13.
DATA ANALYSIS/CALCULATIONS
6
14.
FORMS AND DATA SHEETS
6
15.
REFERENCES
6

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SOP No. ADM-01-05
Date Revised 04-22-14
Page 3 of 7
1. Definitions
Abbreviations/definitions are also provided in the text.
1.	Performance Report = A report documenting the outcome of a product
efficacy evaluation as tested with a specific method. The performance
report contains information referred to in Section 12.1.
2.	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.
2. Health and
Safety
Not applicable
3. Personnel
Qualifications
and Training
Refer to SOP ADM-04, OPP Microbiology Laboratory Training.
4. Instrument
Calibration
Not applicable
5. Sample
Handling and
Storage
Not applicable
6. Quality Control
1.	The OPP Microbiology Laboratory conforms to 40 CFR Part 160, Good
Laboratory Practice (GLP) Standards. Appropriate quality control
measures are integrated into each SOP.
2.	Studies are tracked in the Master Schedule which is maintained
electronically and archived as per SOP QA-04, Master Schedule
Preparation.
7. Interferences
1. Incomplete paperwork and documentation can impede the report process
and may impact further regulatory and enforcement actions.
8. Non-
conforming
Data
1. Any nonconformance will be documented and appropriate corrective
action(s) will be implemented. Procedures will be consistent with SOP
ADM-07, Non-Conformance Reports
9. Data
Management
1.	Data will be archived consistent with SOP ADM-03, Records and
Archives.
2.	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.
10. Cautions
None
11. Special
Apparatus and
None

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SOP No. ADM-01-05
Date Revised 04-22-14
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Materials

12. Procedure and
Analysis
A Performance Report consists of information associated with testing of a
product and may include documents such as the study protocol, data sheets,
labels, chain of custody (COC) forms, as well as documents required under
Good Laboratory Practice Standards such as the GLP Statement and Quality
Assurance audit information. The Performance report and Biological Report
of Analysis form are sent along with a transmittal memo, which summarizes
the testing history and is signed by the Branch Chief, to Antimicrobials
Division (AD), in the Office of Pesticide Programs (OPP). Compile and
finalize the Performance Report within 14 business days after all data
collection is completed for the product analysis.
12.1 Contents and
Format of a
Typical
Performance
Report
The Performance Report is assembled sequentially and consists of, but is not
limited to, the following:
a.	Quality Assurance Unit Statement
b.	Title Page

c.
GLP Statement (original signatures)

d.
Study Protocol and Attachments

e.
Test Coordinator and Analyst Signature Page (original signatures)

f.
Data Summary Sheets

g-
Photocopies of Test Data Sheets (e.g., Test Information Sheet,
Results Sheet, Confirmation Sheets, Carrier Count Data and
Spreadsheet, Vitek printouts, and Test Sheets related to
Neutralization Confirmation Assays [when applicable]).

h.
Photocopies of the Chain of Custody (Documentation for samples
tested)

i.
Photocopies or photographs of product label on sample container.

j-
Refer to Attachment A for general report format.

k.
Accompanying the Performance Report is (are) the completed
Biological Report(s) of Analysis (EPA Form 8510-14).
12.2 Preparation of
the Report
a.
Assemble the Draft Report and associated BRA, check it for
completeness, and submit to another analyst for peer review.

b.
Complete a Report Preparation and Quality Control Checklist (see
section 14).

c.
Prepare a draft transmittal memo.

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SOP No. ADM-01-05
Date Revised 04-22-14
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d.	Once the peer review is complete, submit the Draft Report to the
Study Director or designee who reviews the Draft Report for errors
and completeness.
e.	Incorporate any suggested corrections/changes made by the Study
Director.
f.	Alternatively, if there are only minor comments, the Study Director
may submit the Draft Report directly to the Quality Assurance Unit
(QAU).
12.3 Quality
Assurance Unit
Review of a
Draft report
a.	After completion of the Draft Report and all subsequent
corrections/changes, submit the report to the QAU.
b.	The QAU reviews the Draft Report for completeness and determines
whether additional revisions/corrections are necessary.
c.	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.
d.	The Lead Analyst ensures all required revisions/corrections are
completed by the appropriate analyst(s) and submits the final report
and signed Biological Report of Analysis (BRA, EPA Form 8510.14)
(see section 14), to the QAU for final review. Once reviewed by
QAU, the Lead Analyst page stamps the final report.
e.	The Quality Assurance Officer (QAO) verifies that all corrections or
required revisions have been made and issues the QA statement.
f.	The Lead Analyst 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.
g.	The Branch Chief reviews the Final Performance Report and adds
signatures and date to the BRA(s).
h.	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.
i.	Send a "Record of Customer Feedback" form (see SOP ADM-08) 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).
j. Scan the transmittal memo, BRA and full report and store
electronically.

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SOP No. ADM-01-05
Date Revised 04-22-14
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13. Data Analysis/
Calculations
1. None
14. Forms and Data
Sheets
1.	Attachment A: Report Format-Hospital /General Disinfectant Claims.
2.	Test sheets are stored separately from the SOP under the following file
names:
Report Preparation and Quality Control Checklist ADM-01-05 Fl.xlsx
Biological ReP°rt°f Analysis (EPAHQ Form ^,^5 F2 x|sx
0j10-14)
15. References
1. None.

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SOP No. ADM-01-05
Date Revised 04-22-14
Page 7 of 7
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 (Not numbered)
QA Statement (Not numbered)
GLP 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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