How To Properly Carry Out An Analytical Method Transfer

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How To Properly Carry Out An AnalyticalMethod
Transfer
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• Analytical method transfer constitutes a critical
  step in research as it
• stimulates drug discovery, clinical testing, and
  long-term stability testing ,etc. Method transfer
  is achieved to document the fact that a testing
  laboratory has the qualification of conducting
  already validated analytical methods for
  generating GLP compliant data.
• Types of Analytical Method Transfer
• Comparative Testing
• The comparative testing analysis is carried out
  by the two laboratories on the same API. The
  acceptance criteria after the analysis are
  matched. Both the acceptance variability and
  criteria are mentioned in the transfer protocol.

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• Co-Validation Testing
• The co-validation testing is achieved with an
  inter-laboratory verification process conducted
  by both the transferring and receiving
  laboratories. Using the transfer protocol, the
  assessment is concluded and reproducibility of
  the method is achieved.
• Revalidation
• Partial validation of the analytical method is
  also considered in analytical method transfer.
  Sometimes, this is necessary in the case of a
  method change.
• In some cases, the laboratories can opt for
  transfer wavier, following which the need for
  analytical method transfer is eliminated. The
  method

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• is transferred to the receiving laboratory
  without generating inter-lab data.However, this
  is only possible after the risk analysis of the
  laboratorys experience, knowledge, and
  criticality of the method.
• Key Points of Consideration for Analytical Method
  Transfer
• ? The receiving laboratory should evaluate the
  availability of the test
• material, equipment, and system of the method
  transfer beforehand.
• ? The receiving laboratory should calibrate these
  systems or equipment prior to method transfer so
  that the specifications can be achieved and
  compliance can be maintained.
• ? The transferring laboratory should ship
  standards, samples, methods, validation methods,
  and required documents to the receiving
  laboratory prior to the AMT.

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• ? The transferring laboratory should train the
  receiving laboratory for
• handling the critical aspects whenever and
  wherever required.
• ? Before starting the analytical method transfer,
  the receiving laboratory is required to conduct a
  test run for methods, procedures, and processes.
• ? All the involved scientists and lab analysts
  should be properly trained to conduct the method
  transfer without any errors.
• ? Only a single instance of the API should be
  tested. This is due to the
• fact that method transfer is not a manufacturing
  procedure. Hence, additional lots are tested only
  when required.
• ? The protocol should be reviewed and approved by
  receiving and
• transferring laboratories. This should include
  acceptance criteria, performance parameters,
  required materials, and result evaluation.

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