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1.0 PURPOSE
The purpose of this procedure is to provide guidelines for the studies required, propose
minimum requirements and acceptance criteria for the transfer of analytical methods.
Guidelines are also provided for the design, approval, and execution of analytical method
transfer protocols.

2.0 SCOPE
This procedure applies to analytical methods transferred from any originatinglaboratory to
any receiving laboratory, either internal or external to XXXXX Labs Pvt Ltd.

This procedure outlines the minimum studies required for the transfer ofanalytical
methods. Additional or different transfer approaches may beconsidered and documented in
the method transfer protocol with scientificjustification.

This procedure applies to chemical analytical methods used for the testing ofAPI,
excipients, applicable commodities, packaging components, cleaningsamples, in-process
samples, and finished pharmaceutical products.

This procedure does not apply to microbiological methods or device testmethods.

3.0 RESPONSIBILITIES
3.1 Originating Laboratory
 Provides a copy of the completed test methods, validation reports Validation Change
Requests (VCR), and specifications, if available.
 Prepares the transfer Protocol. The protocol will address all testing required for the
product or material and the rationale to justify the requirements for method transfer or

the waiver of transfer for a specific test method.

 Provides the Receiving Laboratory with sufficient samples to complete the method
transfer activities.
 Supplies a reference standard and any specialty chemicals or columns if necessary.
 Executes the Originating Laboratory portion of the Protocol, if applicable.
 Provides documented consultation or method-specific training to the Receiving
laboratory to assist in execution of the protocol as needed.
 Approves the Protocol along with the Receiving Laboratory.
 Authors, approves, and obtains approvals for the final method transfer report and
makes final determination on the success of the transfer.
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 Provides safety precautions related to handling of the materials, appropriate
personal protective equipment and material safety data sheet (MSDS).

NOTE: Based on business need the responsibilities for transfer protocol and report
preparation may be subject to modification. Only qualified personnel can perform the
tasks without deviation from the established approval process.

3.2 Receiving Laboratory

 Reviews the methods, validation reports, and other documentation provided to
ensure that the method is suitable for transfer.
 As deemed necessary, conduct feasibility runs for identification of possible issues that
may need to be resolved prior to finalization of the transfer protocol.
 Reports any problems experienced and make applicable suggestions to the
originating laboratory.
 Reviews and approves the Validation Change Request (VCR) and Transfer Protocol
along with the Originating Laboratory.
 Reviews and approves method validation protocol along with Originating
Laboratory in the event of a co-validation.
 Executes the Receiving Laboratory portion of the Transfer Protocol and provides
 written summary results of analyses and copies of raw and/or processed data,
representative chromatograms, charts, etc. to the Originating Laboratory.
 Evaluates the results for compliance with the Transfer Protocol’s acceptance criteria.

 Collaborates with the originating Laboratory in resolving issues that may arise during
the execution of the protocol.
Approves the final method transfer report along with the originating Laboratory
NOTE: Based on business need the responsibilities for transfer protocol and report
preparation may be subject to modification. Only qualified personnel can perform the
tasks without deviation from the established approval process.

4.0 DEFINITION/ABBREVIATIONS
This is a list of definitions cited within this procedure:
Terms or Phrase Description
Analytical Test Method The procedure for performing a test or measurement that describes,
in detail, the steps necessary to perform each test. This may include
but is not limited to sample preparation, reference standard and
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reagents preparations, use of the apparatus, generation of the
calibration curve, and use of formulae for calculations.
Change Control A formal system by which qualified representatives of appropriate
disciplines review proposed or actual changes that might affect a
validated status. The intent is to determine the need for action that
would ensure and document that the system is maintained in a
validated state.
Co-Validation When a Receiving Laboratory participates in the method validation
study. This is typically intermediate precision.
Deviation Any excursion outside the scope of acceptance criteria specified in
the protocol that occurs during the execution of the protocol.
Method Transfer The systematic process that qualifies a receiving laboratory to
perform an analytical procedure previously not performed. This
process is coordinated between the originating laboratory and the
receiving laboratory.
Terms or Phrase Description
Method Transfer Protocol A document containing minimally the purpose, experimental
design, and acceptance criteria for the transfer of the analytical
method to be transferred, and the responsibilities of the originating
and the Receiving Laboratories.
Originating Laboratory Laboratory from which the analytical method is transferred. The
originating laboratory is where the validation of the analytical
procedure is conducted.
Receiving Laboratory The laboratory to which the analytical method is transferred.

Simple Method Routine tests (pH, LOD, ROI, Karl Fischer, Heavy Metals, ID-IR,
ID-UV) which can be executed by any trained, qualified analyst.
Specifications A list of tests, methods, and appropriate acceptance criteria that are
numerical limits, ranges, or other criteria for the tests described. It
establishes the set of criteria to which the material should conform
to be considered acceptable for its intended use.

Validation Documented objective evidence that provides a high degree of

assurance that a specific process will consistently produce a
product, meeting its predetermined specifications and quality
attributes.

5.0 PROCEDURE

5.1 General considerations

The purposes of performing method transfer studies are:
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 To demonstrate that the suitability of all testing methods used shall beverified under
actual conditions of use.
 To verify that the method will perform in the Receiving Laboratory as it didduring the
validation studies.
The transfer of methods, when necessary, may involve sending the appropriate subject
matter expert (SME) to train the lab analysts in the receiving lab priorto a formal transfer
1study. The completion of the training will be documented in a notebook by the
Receiving Laboratory.

The Method Transfer Protocol consists of studies that will demonstrate that the
Receiving Laboratory can successfully perform the method as written in the test
procedure without any additional information. If additional information is required to
successfully execute the method, this information must be documented in the analyst’s
notebook and included in the final test method.

The intended use of the method as well as the method’s difficulty to execute
(complexity) will dictate the needed steps in the transfer process. Chromatographic
methods (TLC, HPLC, GC) are classified as moderately complex to complex and require

formal method transfer. The acceptance criteria presented in this procedure may be
modified or adjusted based uponactual needs and method / equipment capabilities.
Justification for all modifications from the approach presented in this procedure must be
included in the individual method transfer protocol.

Methods transferred from one laboratory to another require an approved Method Transfer
protocol and a Method Transfer report. The Method Transfer protocol and report must be
approved by the appropriate signatories as specified in the Approvals Section prior to
beginning any transfer activities.

The test method shall include but not be limited to the following solution preparation
elements:

 System Suitability
 Solution Preparation
 Reference Standards
 Stability of Solutions (if available)
 Description of Equipment
 Special Handling Instructions (i.e. protect from light, refrigeration needed, special
glassware…etc.)
 Calculations
 How to Report data
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All equipment involved in the method transfer must be qualified and calibratedin the
operating range established in the method prior to use.

5.2 Method transfer approaches

5.2.1 Co - Validation

Specific method validation studies may be performed concurrently by the validation and
the Receiving Laboratory to successfully transfer the method. These studies may include,
Quantitation Limit (QL) and intermediate precision. If the method transfer activities are
performed after issuance of the Method Validation Report, the transfer will be performed
as described in the Comparative Testing Section.

If the transfer is performed concurrently with the validation, a separate transfer protocol
is not required. However, the acceptance criteria for method transfer must be clearly
stated in the validation protocol, which in this case must be approved by the receiving
laboratory. The Method Validation Report will include the results from the transfer and a
statement as to whether or not the method was successfully transferred.
5.2.2 Comparative Testing
Comparative testing involves testing by both the Originating and Receiving Laboratories
on the same lot of material to demonstrate the ability of the Receiving Laboratory to
successfully perform the method.
5.2.3 Simple Methods

Methods that are considered “simple” such as Organoleptic or Identification test

methods only require a Validation Change Request (VCR) for technical report for new
products to document that a formal method transfer is not required.
The target acceptance criteria should be based on the known precision and accuracy of
the method. Table 1 provides example studies and proposed acceptance criteria for
assay, impurity, residual solvents, particle size, elemental analyses, and cleaning
validation methods. If based on developmental feasibility studies, methods will require
different acceptance criteria; this will be documented in the method transfer protocol.
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The method transfer protocol will supersede this SOP based on sound scientific
rationale.
Suggested Studies and Acceptance Criteria (Comparative Testing) – The final
experimental design and acceptance criteria in the Method Transfer Protocol may be
modified with appropriate scientific justification.

Table 1.

Type of Method Suggested Studies Acceptance Criteria

Assay (Finished For each laboratory, the %RSD for
Product) the six (6) preparations is ≤ 3.0%
Six (6) sample preparations of
Absolute difference between the
the same Batch or Lot (not the
means for each laboratory ≤ 3.0%
same sample) by both
For each laboratory, the %RSD for
Originating and
the six (6) preparations is ≤ 2.0%
Receiving Laboratories.
Assay
(API/Excipients/Raw Absolute difference between the
Materials) means for each laboratory ≤ 2.0%
Impurities/ Six (6) sample preparations of For each laboratory, the %RSD for
Degradation the same Batch or Lot (not the the values for the six (6)
Products (applies only same sample) by both preparations is ≤ 15%.
Known Impurities up to 0.2%,
for samples containing Originating and Receiving
difference ≤ 25% .
measurable quantities Laboratories. Known Impurities between 0.2% -
of degradation 0.5%, difference ≤ 20%.
products) Known Impurities between 0.5% -
1.0%, difference ≤ 10%.
The impurity profile obtained by
each laboratory should be similar.
S/N for QL or PQL is at least NLT
10:1.

Sensitivity (QL / PQL) Specificity – known impurities are

suitably resolved
from each other and from the active
Specificity

Type of Method Suggested Studies Acceptance Criteria

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Impurities/Degradation Six (6) sample preparations ingredient and no peaks from diluent or
Products (applies to of the same Batch or Lot by system interfere at the expected
retention times of the known impurities.
samples that do not bothOriginating and
contain degradation Receiving Laboratories For each laboratory, the %RSD for the
products) spiked at the specification values for the six (6) preparations is ≤
limit for each impurity. 15%.
Known Impurities up to 0.2%,
difference ≤ 25%.
Known Impurities between 0.2% - 0.5%,
difference ≤ 20%.
Known Impurities between 0.5% - 1.0%,
difference ≤ 10%.
The impurity profile obtained by each
laboratory should be similar.
S/N for QL or PQL is at least NLT 10:1.
Sensitivity (QL/ PQL)
Specificity – known impurities are
suitably resolved from each other and
Specificity
from the active ingredient and no
peaks from diluent or system interfere at
the expected retention times of the
known impurities.

Type of Method Suggested Studies Acceptance Criteria

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Six (6) sample preparations For each laboratory, the %RSD for the
of the same Batch and Lot recovery values for the six (6) preparations is ≤
by both 15%.
Residual Solvents Originating and Receiving Absolute difference between the mean
Laboratories spiked with recovery values for each laboratory is ≤ 15%.
the residual
solvent(s) of interest at the
specification limit. S/N for QL or PQL is at least NLT 10:1

Sensitivity(QL /PQL) Specificity – specified solvents are suitably

resolved from each other and no peaks from
Specificity diluent or system interfere at the expected
retention times of the specified solvents.
Particle Size Six (6) sample preparations Overall RSD for 6 results shall be NMT 10.0%
by both for particles >5 μm
Originating and
Receiving Laboratories. Depending on the type of particle size test,
other acceptance criteria may be used.

Elemental Analyses Six (6) sample preparations For each laboratory, the %RSD for the
[AA or ICP] of the same Batch or Lot recovery values for the six (6) preparations is ≤
(not the same sample) by 3.0%.
both Originating and
Receiving Laboratories at Absolute difference between the means for
the specification limit. each laboratory ≤ 3.0%.
Cleaning Six (6) sample preparations Acceptance criteria will be reflective of the
Verification/ spiked with API of the feasibility studies conducted during method
Validation same Batch or Lot (not the development.
same sample) by both
Originating and Receiving
Laboratories at the RCL.

5.3 Protocol cancellation

Protocols that have been approved and data collected must have a reportwritten to cancel the
protocol. The report must state the reason why theprotocol is canceled and reference any data
generated.
5.4 Method transfer protocols

A Method Transfer Protocol shall include the following but is not limited to:
 The name and location of both the Originating and Receiving Laboratories.
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 A rationale and justification for each method which requirestransfer.
 The purpose and scope of each method and its capabilities.
 An attached copy of the proposed and approved analyticalmethod(s) to be
transferred.
 Transfer studies to be performed.
 A section on how deviations from the protocol will be addressed.
 The document number and name of the method being transferred.
 Appropriate Document Approval Signatures (Approvals Section).

5.5 Method Transfer Reports

Method Transfer Reports shall contain the following but is not limited to:
 The purpose and scope of the method and its capabilities.
 The name and location of both the Originating and Receiving Laboratories.
 The document number and name of the method being transferred.
 A copy of the final analytical method transferred.
 Data from the transfer studies performed.
 A summary of the experimental approach for each study and theresults obtained,
including chromatograms and graphs as applicable.
 The acceptance criteria for each experiment.
 Listing and summary of any deviations.

 Statement as to whether or not the method was successfullytransferred.

 Appropriate Protocol Approval Signatures (Approvals Section).

5.6 Documentation and Approval

Method Transfer Documents are approved by the following personnel:
 Protocol Author.
 Originating Laboratory Management.
 Receiving Laboratory Management.
 Originating Laboratory and Receiving Laboratory Quality.

5.7 Acceptance Criteria Non- Conformance Incidents and Deviations

Any acceptance criteria non-conformance events (data not meeting the
predeterminedacceptance criteria established in the approved method transferprotocol) must
be investigated per QC016-01.
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If the investigation determines that the method, as written, does not containadequate
information and/or instruction to execute the procedure as intended,the method must be
revised to include all pertinent information to ensureconsistent application of the method.
If the decision is to amend the transfer protocol or to proceedwithoutadditional change the
rationale and justification for that decision must bedocumented and approved.Any deviations
to the transfer protocol made during the transfer executionmust be documented and approved
and justified in the final method transferreport.

5.8 Document Storage

The original documents for transfer protocol and report will be stored in the QA documents
center.

5.9 Document Information

Update “Roles and Responsibilities section of Originating Laboratory and Receiving
Laboratory. Add following note in each section;
NOTE: Based on business need the responsibilities for transfer protocol and report preparation
may be subject to modification. Only qualified personnel can perform the tasks without
deviation from the established approval process.
6.0 RECORDS / FORMS
6.1 Test Method Validation Procedure (XXX/PH/SOP/026-01)
6.2 ISPE Good Practice Guide, Technology Transfer, International Society for
Pharmaceutical Engineering, 2003

7.0 REFERENCES
Nil
8.0 CHANGE HISTORY
Current SOP No. &
S. No Superseded No. Description of Changes made
Date