What You Need To Learned About Analytical Method Transfers In Various Stages Of Drug Development?

Analytical method transfers are referred to as documented processes of qualifying a laboratory so that it can utilize a validated analytical procedure which has been originated or developed in some other laboratory. It is a pre-requisite for the receiving laboratory to possess the procedural knowledge and analytical testing performing ability as intended in the concerned guidelines.

Risks involved in accomplishing method transfers between two laboratories – 

Some of the common risks involved while performing method transfers are as indicated below –

The type of analytical method that it is being transferred. (It can either be qualitative or quantitative).

The capability of the method and the past method performance.

The types of test samples that are being employed here in the analytical method transfers.

Differential nature of the method transfers and their effects on the overall performance, quality of the product, safety and efficacy.

Approaches to Analytical Method Transfer –

There are three different approaches to accomplish analytical method transfers –

Co-validation –

Here, the receiving laboratory steps ahead to participate in the initial activities of the method transfer process. The laboratory performing the validation of these test procedure qualifies itself to run such a test procedure. The assessment of the analytical method by receiving laboratory should be made according to the pre-approved protocol, which specifies its acceptance criteria.

Analytical Method Transfer Waiver –

Method transfer protocols may be waived off in following cases –

If the analytical method being transferred in pharmacopoeia remains unchanged for a longer period. Here, the purpose of analytical method validation comes into foreplay.

Analytical Method Revalidation –

Another most commonly applied approach for the analytical method transfer is the Analytical Method Revalidation. Characteristics or the parameters for the analytical method revalidation has been defined in the chapter 1224/ICH Q2 of the USP.

What are the responsibilities assigned to the personnel handling the Analytical Method Transfer Unit?

Following responsibilities are assigned to the members of the analytical method transfer units:

  • Train the analyst and other staff from the quality control department about the analytical method being transferred.
  • Provide assistance to the QC team in matters related to the results of QC testing analysis.
  • Defining all the analytical methods to be transferred to test a product, its starting material, and sample used for cleaning purpose.
  • Define the sampling methods, experimental design, and acceptance criteria for the analytical method selected for transfer.
  • Demonstrate the robustness of the analytical method being developed for the purpose of transfer and support it with a relevant validation report.

What are the responsibilities of the receiving unit?

The responsibilities assigned to the receiving unit in the analytical method transfer process are as follows –

  • Ensure that everyone receives an adequate level of training and only those with a certain level of experience are employed.
  • Proper execution of the protocol for analytical method transfer.
  • Accomplish an adequate level of validation for supporting the analytical method implementation.
  • Generation of the approved analytical method transfer report.

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