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Transfer of Analytical Methods

The transfer of analytical methods between laboratories is crucial and requires careful planning and execution. There are 10 key steps to a successful analytical method transfer: 1) Ensuring the availability of a validated method and documentation, 2) Procuring any necessary equipment and instruments, 3) Training personnel, 4) Acquiring samples, standards, chemicals and reagents, 5) Developing a standard test procedure, 6) Creating a transfer protocol, 7) Executing the transfer, 8) Reporting any deviations, 9) Evaluating results against acceptance criteria, and 10) Obtaining final approval or rejection of the transfer. Careful attention to all steps is necessary to validate that the receiving laboratory is qualified to generate valid results using the new method.

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Bhaskar Napte
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663 views3 pages

Transfer of Analytical Methods

The transfer of analytical methods between laboratories is crucial and requires careful planning and execution. There are 10 key steps to a successful analytical method transfer: 1) Ensuring the availability of a validated method and documentation, 2) Procuring any necessary equipment and instruments, 3) Training personnel, 4) Acquiring samples, standards, chemicals and reagents, 5) Developing a standard test procedure, 6) Creating a transfer protocol, 7) Executing the transfer, 8) Reporting any deviations, 9) Evaluating results against acceptance criteria, and 10) Obtaining final approval or rejection of the transfer. Careful attention to all steps is necessary to validate that the receiving laboratory is qualified to generate valid results using the new method.

Uploaded by

Bhaskar Napte
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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10 STEPS IN ANALYTICAL METHOD TRANSFER

The transfer of analytical method from analytical development laboratory (considered as transferor) to
quality control laboratory (considered as transferee) is crucial. There are many important factors which
need to be considered during analytical method transfer.

1. Availability of method validation/method verification report


2. Availability of suitable instruments/equipments
3. Availability of trained and skilled manpower
4. Availability of sample and standard
5. Availability of chemicals and reagents
6. Availability of standard test procedure/Method of analysis
7. Availability of analytical method transfer protocol
8. Method transfer execution
9. Deviations/Incident if any
10. Conclusion

Let us discuss one by one in details.

1. Availability of method validation/method verification report: The transferor shall either validate
or verify analytical method based on requirement. The in-house developed method must be
validated and in case if pharmacopeias method is used, method verification can be done. The
method validation/verification gives an important information about method performance and
also confirms the suitability of method for intended purpose.

2. Availability of suitable instruments/equipments: Unless and until QC lab is well equipped with
required instrument/equipment, analytical method transfer can’t be started. So, it is the
responsibility of QC lab to make sure that the lab is well equipped with required
instrument/equipments. If the required instrument/equipment is not available, the same shall
be procured and must be qualified before use. So, planning of method transfer becomes very
crucial in case of new product launch. The unavailability of instrument/equipment may
jeopardize the launch. To avoid such scenario, the method development team and QC team
must discuss the method transfer requirement well in advance such that any unmet
requirement will get fulfilled and product launch will not get hampered.

3. Availability of trained and skilled manpower: The availability of skilled manpower is very
important for implementing analytical method at QC. If the QC team is not well aware about the
techniques used, for example, HPLC; then there is no way that analytical method transfer will
get happen as expected. Hence, both QC and method development team shall discuss such need
in well advance to avoid chaos during method transfer activity.
4. Availability of standard and sample: This is very important part of analytical method transfer;
unless and until you have standard and sample in hand, you can’t start method transfer. Same
batch of sample must be sued at method development lab and QC lab as result from both labs
needs to be compared to conclude successful method transfer. The transfer of sample and
standard from one location to another location shall be done at recommended storage
condition (e.g. 2-8°C) to avoid standard/sample degradation. This is very important part of
method transfer because sample storage will have direct impact on analytical result. The sample
selected for method transfer must and should be homogeneous to avoid variation in analytical
result due to sample.

5. Availability of chemicals and reagents: Unless and until required chemicals and reagents are
available, analytical method activity can’t be conducted. Many times, the laboratories are well
equipped with required chemicals/reagents, but in case if any special chemicals/reagents is
require, laboratory must identify such situation and procure the required items well in advance
to avoid delay.

6. Availability of standard test procedure: Availability of standard test procedure or analytical


method is most important requirement during analytical method transfer. This is the
fundamental document based on which entire method transfer activity is based. The availability
of standard test procedure triggers many actions and can help to identify techniques,
chemicals/reagents used. The standard test procedure must be approved by the development
lab and it must contain preparation of analytical solutions (such as mobile phase, buffer
solution, standard and test solution, analytical conditions in case of chromatographic
techniques, calculation formula etc). In case of chromatographic techniques (HPLC, GC), the
availability of reference chromatograms gives huge advantage.

7. Availability of analytical method transfer protocol: The availability of approved method transfer
protocol is the most important part. The method transfer protocol shall be prepared by
transferee (QC) as their requirement can be fulfilled precisely. The reference of SOP, based on
which protocol is prepared, the reference of STP, the batch number of sample to be used must
be defined in protocol. The protocol must be signed by both transferee and transferor prior to
method transfer activity. The number of sample & standard preparations must be well defined
in protocol. The method transfer protocol must define acceptance criteria for specific test. For
example, in case of assay, the difference between average result obtained by transferee and
transferor shall not be more than 2.0%.

8. Method transfer execution: Once all requirements are met; the method transfer experiments
can be started. The Transferor must execute the experiment and submit result to transferee.
Upon receipt of results of transferor, the transferee shall execute the experiment and report the
same. The results must be evaluated for the acceptance criteria.

9. Deviations/Incident if any: Both laboratories must report any deviation or incident happened
during method transfer experiment. The impact of deviation/incident on analytical result must
be evaluated. In case if the subject deviation/incident has impact on analytical result, the
method transfer experiment must be repeated and an appropriate CAPA must be devised.

10. Conclusion: Based on the results generated at both laboratories, authorized person (e.g. QA
Head) shall approve or reject the method transfer. In case if all the results are well within
predefined acceptance criteria, QA head can approve the method transfer activity. Once the
method transfer is approved by QA head, the transferee/receiving lab is considered to be
qualified to use the test procedure and the results shared by them are considered valid.

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