PROGRAM-WIDE PROCEDURE Document #: Version #: 0

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Medicine FDA-OFVM-3 Page 1 of 14
Title: Effective Date:
10/16/2014
Methods Development, Validation, and Revised:
Implementation Program 09/30/2014

Sections included in this document/(Change History)

1. Summary
2. Scope/Policy
3. Responsibilities
4. Procedures
5. Records
6. Supporting documents
7. Attachments

Document history

1. This document establishes and describes the standard operating procedure

Summary (SOP) for the approval and tracking of Foods and Veterinary Medicine (FVM)
Program analytical method development proposals for implementation in U.S.
Food and Drug Administration (FDA or the Agency) laboratories for regulatory
compliance, enforcement and surveillance purposes. An important
component of this process will include coordinated alignment of the method(s)
to be developed with Center and Program needs and with identified Agency
priorities.

2. This SOP applies to all method development activities across the FDA FVM
Scope/Policy laboratory science enterprise comprised of the operating units of the FVM
Directorate [the Office of Foods and Veterinary Medicine (OFVM), the Center
for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary
Medicine (CVM)], in conjunction with the foods and veterinary medicine
operations of the Office of Regulatory Affairs, ORA. The FVM Science and
Research Steering Committee (SRSC) will provide direct oversight to all
Cross-Center Project Collaborations and all Multi-Laboratory Validation (MLV)
processes deemed necessary through the appropriate Research Coordination
Group (RCG).

Preliminary, short-term or exploratory investigations that focus on the

feasibility of a new method and/or technology and any subsequent Single
Laboratory Validation (SLV) study may be managed wholly by the respective
Center and Office line management structure; however, any and all such
activities are expected to be processed within the Component Automated
Research Tracking System (CARTS).

All relevant presentations and publications associated with method

development research will be electronically attached to the appropriate
CARTS entry.

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FVM Program (CFSAN, CVM, or ORA) line management will ensure that there
is appropriate communication and collaboration between the applicable
technical advisory groups (TAGs) (e.g. Bacteriological Analytical Manual
(BAM) Council, Pesticide Steering Committee, etc.) and that the investigator
reviews CARTS for similar research projects before any studies are proposed
and entered into CARTS. This type of communication is especially critical in
emergency response activities.

The FDA FVM enterprise recognizes it must demonstrate (through defined

validation studies) that all methods used to support regulatory actions meet
agency requirements and are fit for their intended use. However, this SOP is
a forward-looking document; the requirements described here will only apply
to newly developed methods and not existing methods. Whereas most of
FDA FVM analytical methods currently employed for regulatory applications
have not been validated by the new standards described herein and in the
methods validation guidelines (see links to methods validations guidelines in
Section 6), their documented performance over the course of many years of
use provides the necessary evidence to support their reliability. Previously
developed and validated methods met the quality standards defined and
required at the time they were developed and adopted for use and have been
demonstrated through time and application for their intended use. However,
this document defines criteria for methods development and validation as of
the effective date. Moving forward, the continued assessment of current
methods, future method needs (i.e. modifications, extensions, and the
incorporation of advanced technologies) will require the RCGs, associated
TAGs, and the respective Methods Validation Subcommittee (MVS) to make
recommendations on validation criteria to be fulfilled and what past methods
may be subjected to reevaluation.

This SOP is intended to provide guidance and instructions to FDA staff and
represents current Agency thinking on this topic. It does not create or confer
any rights for any person and does not operate to bind the FDA or the public
in any way. An alternative approach may be used if such approach satisfies
the requirements of applicable statutes and regulations. It is intended for use
by FDA personnel, but may be made available electronically to the public.

3. FVM Program Executive Council, FPEC:

Responsibilities
• Provides real and visionary strategic direction to the SRSC, and
constituent components of the FDA Foods and Veterinary Medicine
Program (CFSAN, CVM, and ORA)
• Provides approval of the Annual Methods Development Plan (AMDP)
• Acts as an oversight body
• Involves the FVM Governance Board in decision-making, as appropriate

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Implementation Program 09/30/2014

OFVM Science and Research Team

• Resides within OFVM
• Responsible for providing strategic direction and leading methods
development activities across CFSAN, CVM and ensuring integration
of Center research and methods development with corresponding
ORA activities
• Responsible for assembling and tracking progress of the AMDP

FVM Program Science and Research Steering Committee, SRSC:

• Acts as the final decisional body in cases that cannot be resolved at the
RCG level
• Reviews overall method development and validation work twice a year
to ensure alignment of activities with FVM Program and Agency goals
• Provides summary reporting on method development and validation
activities to the FPEC on an annual basis
• Ensures overarching coordination of methods development and

validation efforts across the FVM Program

Research Coordination Group, RCG (e.g. Microbiology, Chemistry, etc.):

• Ensures AMDP is aligned with the FVM Strategic Plan and provides
clearance for submission to the SRSC
• Ensures recommendations from the RCG and TAGs are communicated
to respective Centers and office line management
RCG Methods Validation Subcommittees, MVS:
• Has an oversight responsibility for MLV studies. Refer to FVM document
titled, “FDA Office of Foods and Veterinary Medicine Method Validation
Subcommittees Charter”
• Charged with prioritizing method validation needs based on

recommendations made by the appropriate RCG

Respective Center and Office Line Management:

• Ensures that there is appropriate collaboration between the Center(s)
and ORA
• Ensures that the investigator reviews CARTS for similar research
projects and consults with the appropriate TAG, if applicable, before
initiation of any method development activities
• Ensures CARTS project entry, progress reporting, and tracking activities
are completed in a timely manner
Technical Advisory Groups, TAGs:
• Acts collaboratively without Center or Office bias as a technical advisory
body to the RCGs, MVSs, and the SRSC
• Collectively represents the subject matter experts (SME), state-of-the-art
knowledge base, including knowledge of any best practice(s), for a
technical area within the FDA

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Investigator(s):
• Perform methods development research and method validation studies
to improve analytical capabilities of the program including, as
appropriate, service to stakeholders
• Must be cognizant of all quality assurance (QA) and quality control (QC)
criteria that must be met for any method to be considered suitable for
regulatory use

4. The process for identifying and prioritizing the annual listing of method
Procedures development/validation needs; and, for the review and approval of the AMDP
are described below and illustrated in Attachments 1 through 5. Briefly,
Attachment 1 illustrates the coordinated oversight roles of the FPEC, SRSC,
RCGs, and MVSs in the method development process. Attachments 2
through 5, provide more detailed depictions of the entire method development
enterprise (Attachment 2); the process defined for the individual Center level
(Attachment 3); the MLV study level (Attachment 4), and ORA implementation
phase (Attachment 5).

4.1 General Policy and Program Guidance

Identification and Prioritization of Method Development and Validation

Needs
The SRSC will oversee the assembly and prioritization of an annual list of
method development and validation needs derived from activities
associated with the Annual FVM Program Research Prioritization
Conference; and, on an ad hoc basis. This will include all aspects of the
FVM science and research enterprise. This listing will be periodically
updated and disseminated to all FVM Program-related research centers as
it is recognized that these activities will require substantial cross-center
collaboration for successful development, validation and implementation.
Proposals to address these needs can be submitted at any time through
Center-specific review processes and then into CARTS for consideration
and tracking.
• The RCGs, or appropriate subcommittees, will assemble an AMDP,
based on the yearly prioritization process
• Method development/validation work in response to emergent situations
(e.g., melamine, foodborne disease outbreak, natural disasters, etc.)
may take priority over other activities.

Exploratory Investigations
Individual Center/Office personnel may explore new technologies or
develop new methods (up to and including an SLV study) under their
independent discretionary investigations and research process, however:

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• It is line management’s responsibility to ensure that the proposed

project has programmatic value
• Line management will ensure appropriate collaboration between the
Center(s) and ORA in identifying a recognized methods gap, and
defining the proposed method’s “fit-for-purpose” criteria, including
relevant quality standards
• Line management will ensure that the investigator performs a thorough
search of active and archived projects in CARTS to prevent duplicative
efforts and to identify potential opportunities for collaboration
• It is recommended that line management and the investigator consult
with all appropriate RCG(s) and/or TAG(s) prior to the initiation of any
new methods project
• It is recommended that line management and the investigator, in
coordination with the appropriate RCG and/or TAG chair, establish a
timely process for review, comment and concurrence of submitted
project proposals
• All research projects will be submitted and approved through CARTS
• Outcomes of exploratory investigations must be reported in CARTS

Cross Center Collaborations or MLV Initiatives

• All regulatory MLV activities intended to address specific needs

identified by the SRSC must be jointly developed by appropriate

collaborators

• Methods that are deemed suitable for regulatory application and that
have been successfully evaluated at the single laboratory validation
level will be considered for a MLV study in accordance with current
FVM Program validation protocols
• All MLV studies will be coordinated with and overseen by the

respective MVS

• Line management and the investigator, in coordination with the

appropriate RCG and/or MVS chair, should establish a timely process
for review, comment and concurrence of submitted MLV proposals and
the associated action plans
• All approved MLV activities MUST be entered, into CARTS and

tracked

• The SRSC will be the final decisional body in cases that cannot be
resolved at the MVS or RCG level; disputes will be handled as per the
conflict resolution clause in the SRSC Charter

Implementation of Validated Methods

• Methods that have successfully completed the MLV stage are

acceptable for official analyses

• Upon successful completion and approval of an MLV, the method will

be communicated in the appropriate on-line guidance manual and
compliance program guidance

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• ORA will manage the integration of newly approved methods into the
field laboratories, and be responsible for developing and implementing
quality assurance and training plans; implementation may include, but
not be limited to, the following items:
1. Plan for purchasing instruments (if necessary)
2. Training plans
3. Assure QA & QC criteria are addressed and satisfied
4. Proficiency testing plan
5. Assessment and reporting of method performance/program
impacts

Reporting & Oversight

• The Chairs of the Chemistry, Microbiology, Toxicology and
Nanotechnology RCGs will make presentations to the SRSC on a
semi-annual basis, at a minimum. These presentations will include
MVS reviews and evaluations of overall method development and
validation progress to ensure alignment with FVM strategic program
goals and priorities
• Progress reports will be submitted through CARTS on a semi-annual
basis
• Respective Center scientific leadership will review and evaluate
method development and validation progress and outcomes on an
annual basis. Actions may include redirection or termination of studies
that are not making sufficient progress or have been identified as no
longer consistent with current strategic priorities or needs of the FVM
Program
• SRSC will report updates on method development and validation to the
FPEC on an annual basis.

4.2 Identifying and Prioritizing Method Development and Method

Validation Needs
Center components of the FVM Directorate and ORA are responsible for
identifying and documenting a prioritized listing of strategic method
development and validation needs for their respective programs annually. It
will be left to the discretion of each individual component as to the process by
which annual methods development and validation priorities are established.

The SRSC will announce yearly submission deadlines and will not be less
than 60 days prior to the Annual FVM Program Research Prioritization
Conference.

Method development and validation needs that are provided by Center

components of the FVM Directorate and ORA will be consolidated, reviewed,
and discussed by scientific and programmatic leaders invited to the Annual
FVM Research Prioritization Conference with the goal of providing an overall
strategic plan for the upcoming fiscal year.

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Investigators, with line management approval, are encouraged to develop and

submit cross-cutting proposals in support of the methods development needs
identified during the Annual FVM Research Prioritization Conference.

Emergent or unplanned program needs can be identified and communicated

to the SRSC at any time throughout the year.

4.3 Development, Review, and Approval of the Annual Methods

Development Plans
RCGs will develop a prioritized list of method development needs following the
Annual FVM Program Research Prioritization Conference. The RCGs will
work with the SRSC to ensure that the methods development needs are
aligned with FVM and Agency strategic goals and objectives. This activity will
be part of the yearly plan formally presented to the FPEC for review and
approval. Following FPEC approval, the SRSC communicates the plans to
the FVM regulatory science enterprise. As needed, these plans may be
updated by the RCGs with review and approval by the SRSC.

4.4 Development, Review, and Approval of the Annual Methods

Validation Plans
MVSs for each RCG will develop a prioritized list of method validation needs
in consultation with the appropriate RCG following the Annual FVM Program
Research Prioritization Conference. The RCGs will work with the SRSC to
ensure that the validation needs are aligned with FVM and Agency strategic
goals and objectives. This activity will be part of the yearly plan formally
presented to the FPEC for review and approval. Following FPEC approval,
the SRSC communicates the plans to the FVM regulatory science enterprise.
As needed, these plans may be updated by the MVS with review and approval
by the respective RCG and the SRSC.

4.5 Implementation of Multi-laboratory Validated Methods

Successful completion of collaborative multi-laboratory validated methods
shall provide a full and sufficient basis for implementation of the method in
compliance programs and in ORA laboratories for regulatory applications.
ORA shall facilitate appropriate Quality Management System (QMS) and line
management approvals, coordinate Compliance Program Guidance revisions
as necessary, and then implement and benchmark new methods in regulatory
applications. ORA shall communicate method implementation results to FVM
Program stakeholders – internal and external, as appropriate.

5. Annual Methods Development Plans

Records
Annual Methods Validation Plans

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CARTS entries (proposals, status and final reports, etc.) related to individual
methods development and validation activities

Original Data & Method Validation Files and Approvals

Reports of Implementation of New Methods

6. Office of Foods and Veterinary Medicine Method Validation Guidelines for

Supporting Microbial Pathogens
documents

Office of Foods and Veterinary Medicine Guidelines for the Validation of

Chemical Methods

Office of Foods and Veterinary Medicine Microbiology Research Coordination

Group Charter

Office of Foods and Veterinary Medicine Chemistry Research Coordination

Group Charter

Office of Foods and Veterinary Medicine Method Validation Subcommittees

Charter

Membership of Foods and Veterinary Medicine Research Coordination

Groups and Technical Advisory Groups

Foods and Veterinary Medicine (FVM) Science and Research Steering

Committee (SRSC) Charter

ORA Laboratory Manual

7. Attachment 1. Summary Diagram – Part 1: Development and Approval of the

Attachments Annual Methods Development Plan and Oversight of Foods and Veterinary
Medicine Program Method Development Activities through the Science and
Research Steering Committee, Research Coordination Groups and the Foods
and Veterinary Program Medicine Executive Council

Attachment 2. Summary Diagram – Part 2: Method Development Processes.

Separate Processes for New Method, Technology Exploration, or Single
Laboratory Validation Activities and for Joint Collaborations or
Regulatory/Multi-Laboratory Validation Efforts with Implementation in
Regulatory Laboratories

Attachment 3. Proposal, Review, Approval, and Reporting of Methods

Development and Validation Activities: Single-Center activities

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Attachment 4. Proposal, Review, Approval, Reporting, and Implementation

of Methods Development and Validation Activities: Multi-Laboratory Validation
and Collaborative activities

Attachment 5. Office of Regulatory Affairs Implementation of a New Method

Document history
Name & Title
Version Status Date Location of
# (I, R, C) Approved Change History Author Approving Official
SRSC MDV Process
0 I N/A Development SRSC
Subcommittee

Electronic Version/Filename:
Methods Development-Validation-Implementation Program_v09-30-2014.doc
Last edited by:
Nelson, Chad P.
Last edit date/time:
09/30/2014 11:25 PM
Document Owner:
[email protected]
Contributing Authors:
[email protected];[email protected];[email protected];[email protected];
[email protected];[email protected];[email protected];[email protected];
[email protected]
Attachment Figure Graphic File:
FDA-OFVM-3_MDV Program_v0 Attachments_02-21-2014.vsd (Microsoft Visio file)
Attachment Figure Graphic File Owner:
Nelson, Chad P.

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Medicine
Title: Effective Date:
Attachment 1. Summary Diagram – Part 1: Development and 10/16/2014
Approval of the Annual Methods Development Plan and Oversight Revised:
09/30/2014
of Foods and Veterinary Medicine Program Method Development
Activities through the Science and Research Steering Committee,
Research Coordination Groups and the Foods and Veterinary
Medicine Program Executive Council

Identification and Prioritization of MDV Needs:

SRSC Annual FVM Program Research FPEC:

Prioritization Conference:

OFVM

Real and
CVM ORA Visionary
Strategic
direction

CFSAN

Strategic/Program Needs
SRSC Annual
SRSC Summary of
Emergent or Oversees Prioritized Research Approval
Unplanned Needs to
Identifying & List of MDV
Prioritizing FPEC
Program Needs
Needs listing of MDV
needs

Research Coordination Groups & SRSC:

Method Validation Subcommittees:
- Chemistry Prioritized List of methods
- Microbiology development and validation
Annual Methods needs linked to FVM Strategic
- Toxicology Development Aligned with
objectives, Program, SLV,
- Nanotechnology Plan FVM Strategic Emergent Needs or Technology
Plan ? Exploration

Communicate to FVM Regulatory

Science Enterprise

This summary diagram illustrates the development and approval process of the Annual
Methods Development Plan. The diagram also depicts the integrated and coordinated
relationship between the FVM Program Executive Council (FPEC), the Science and
Research Steering Committee (SRSC), the Research Coordination Groups (RCGs) and
their Validation Subcommittees. Identification of method gaps and the establishing
priorities for their development is a major focus for the SRSC during the annual FVM
Program Research Prioritization Conference and relies on considerable input,
evaluation, and approval from the operational organizations (CFSAN, CVM, ORA), the
RCGs, and the FPEC, respectively, with additional appropriate representation from the
National Center for Toxicological Research, the Office of International Programs, and the
Office of the Chief Scientist.

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Attachment 2. Summary Diagram – Part 2: Method Development 10/16/2014
Processes. Separate Processes for New Method, Technology Revised:
09/30/2014:
Exploration, or Single Laboratory Validation Activities and for Joint
Collaborations or Regulatory/Multi-Laboratory Validation Efforts with
Implementation in Regulatory Laboratories

CARTS - (Capture, Approval, Oversight & Reporting)

SRSC: Prioritized List of methods
development and validation needs
linked to FVM Strategic objectives,
Program, SLV, Emergent Needs or Capture in CARTS
Technology Exploration

Efforts completed
Outcome: Documented and
INVESTIGATOR
individually by
TAG CARTS Review approved assessment of a
or PROGRAM: Regulatory Center
Definition of Value ? Coordination
MLV Activity?
& Approval
(SLV, Emergent
new method/ technology or
Method/Project ? Complete ? SLV
Need or Technology
of a new method
Exploration)

Yes

New Method, Technology Exploration or SLV

SRSC:
SRSC: CARTS SRSC
Technical Advisory Group (TAG) Coordinate Conflict Final
Review/Approval
(BAM, PAM, Aquaculture, etc.) appropriate ? Decisional
? Body
RCG/MVS

Cross-Center Outcome: Documented and

Project or MLV approved assessment of a
Completed cross-center project/MLV

Joint Collaboration or Regulatory MLV

Key:
OFVM On-Line
Substituent Guidance
Implementation
QMS & Benchmark Communicate
Line Manuals & of New method
Line Management
Compliance
Method Outcomes to
Management Approvals in FDA
Program Implementation Stakeholders
Decision Guidance Laboratories

ORA

This summary diagram highlights the sequential steps for evaluating the need for a new method,
associated planning and research activities, method validation, and the implementation process.
This diagram also illustrates the overarching role of the Component Automated Research
Tracking System (CARTS) throughout the process.

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Attachment 3. Proposal, Review, Approval, and Reporting of 10/16/2014
Methods Development and Validation Activities: Single-Center Revised:
09/30/2014
Activities

CARTS
(Capture, Reporting, Oversight & Approval)

SRSC: Prioritized List of methods

development and validation needs linked to
FVM Strategic objectives, Program, SLV,
Emergent Needs or Technology Exploration

New Method, Technology Exploration or SLV

Effort completed
INVESTIGATOR individually by
TAG CARTS
or PROGRAM: Regulatory Center (SLV, New
Value ? Coordination
MLV Activity?
Review/Approval
Definition of ? Complete ? Method or
Method/Project Technology
Exploration)

Outcome: Documented and

approved assessment of a new
method/technology or SLV
of a new method

Technical Advisory Group (TAG) To

(BAM, PAM, Aquaculture, etc.) Collab

This diagram shows the development of a new method, technology and/or project,
through to implementation, at the single laboratory validation level. The identification of
methods gaps include many consultative aspects that include, but are not limited to, the
investigator, line management (Center, Office, Division) and technical advisory group(s).
Such method development activities will remain a Center-specific concern through the
Single-Laboratory Validation (SLV) stage.

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Attachment 4. Proposal, Review, Approval, Reporting, and 10/16/2014
Implementation of Methods Development and Validation Activities: Revised:
09/30/2014
Multi-Laboratory Validation and Collaborative Activities

CARTS
(Capture, Reporting, Oversight & Approval)

From SLV

SRSC:
Technical
SRSC
Advisory Group SRSC: Coordinate CARTS
Conflict Final
(TAG) appropriate Review &
? Decisional
(BAM, PAM, RCG/MVS Approval ?
Body
Aquaculture, etc.)

Outcome: Documented
Cross-Center
and approved assessment
Project or MLV
of a cross-center project/
Completed
MLV

Joint Collaboration or Regulatory MLV

To
Implement

This diagram illustrates those procedures and processes for performance evaluation of
methods at the Multi-Laboratory Validation (MLV) level. The decision for any newly-
developed method to proceed to a MLV is the sole responsibility of the Science and
Research Steering Committee (SRSC) and will be made in consultation with the
appropriate Research Coordination Group (RCG) and Method Validation Subcommittee
(MVS), as well as any appropriate TAGs. Disputes will be handled as per the conflict
resolution clause in the SRSC Charter. All MLVs will be managed by the appropriate
MVS.

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Attachment 5. Office of Regulatory Affairs Implementation of a New 10/16/2014
Method Revised:
09/30/2014

From MLV

ORA:

On-Line

QMS & Guidance Implementation

Benchmark Communicate
Line Manuals & of New method
Method Outcomes to
Management Compliance in FDA
Implementation Stakeholders
Approvals Program Laboratories

Guidance

The implementation phase of a newly developed, successfully validated method will be guided
by the principles and practices establish by ORA as published within the ORA laboratory
manual. This includes adherence to Quality Management System (QMS) such as proficiency
testing programs to ensure uniform analytical performance across ORA field laboratories.
Methods will become officially adopted by FVM compliance programs and available in the
appropriate analytical compendia (e.g. Bacteriological Analytical Manual).

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Approval

This document is approved by the FDA Foods and Veterinary Medicine (FVM) Science and Research
Steering Committee (SRSC). The FVM SRSC Project Manager is responsible for updating the
document as change requirements are met, and disseminating updates to the SRSC and other
stakeholders, as required.

APPROVED BY:

//David White// 10/02/2014 //William T. Flynn// 10/21/2014

OFVM Chief Science Officer/Research Director CVM, Deputy Director for Science Policy

//Palmer A. Orlandi// 10/02/2014 //John Graham// 10/09/2014

OFVM Senior Science Advisor CVM, Director Office of Research

//Donald L. Zink// 10/20/2014 //Brian L. Baker// 09/20/2014

CFSAN Senior Science Advisor ORA, Director Office of Regulatory Science

//Vincent K. Bunning// 09/30/2014 //Timothy McGrath// 10/07/2014

CFSAN, Director Office of Regulatory Science ORA, Director Food and Feed Scientific Staff

//Kevin Gaido// 10/08/2014 //William B. Martin// 09/30/2014

CFSAN, Director Office of Applied Research & ORA, Member of the ORA Scientific
Safety Assessment Advisory Council