The drug development process is a lengthy and challenging exercise. In most cases, the pharmaceutical company out-sources either the complete developmental process or a part of it to single or multiple laboratories.
Analytical method transfer
A laboratory that develops and validates an analytical method does not always perform the testing procedure. The parent laboratory may transfer the process to other laboratories, for want of instruments, expertise or the time, or all three.
It is known as the analytical method transfer.
Types of analytical method transfer
The transfer may occur:
- Within the organization or between its various sites.
- Between CMO and multiple CROs
Apart from these, the analytical method transfer can be for any of these four reasons or types:
1. Comparative testing method transfer:
The receiving unit (CRO) and the transferring unit (CMO) analyses a fixed number of samples. The comparison of both the results is essential. The final result must fall under the acceptance criteria.
2. Co-validation amongst the labs
The Laboratories may jointly participate in the validation of the analytical method. The receiving laboratory can be a co-validator and participate in the assessment of reproducibility.
3. Revalidation of the Bioanalytical method:
The receiving laboratory can be a partner in the partial or revalidation of the analytical method which the CMO transfers. Both must follow the guidelines of ICH Q2.
4. Method Transfer waiver
It happens when the composition of the new product is the same as an existing product, the transferred analytical method is identical on both sides, both the units have the same operating personnel.
Points for consideration during method transfer
There are specific points that both the transferring unit and the receiving unit must consider before proceeding with the analytical method transfer process.
- Responsibilities of Method Transferring Unit
- To provide specific training to analysts and other staff
- Assist in the analysis of the results of QC testing
- Describe the methods for transfer, the starting material, and procedure of cleaning sample
- Clearly defining the design of the experiment, method of sampling and criteria for result acceptance
- To provide validation reports, if any, for the processes under transfer
- Demonstrate the robustness of the process
- Provide all the details related to the instruments and the equipment used
- Providing the testing procedures approved by the authority
- Review and approval of the transfer reports.
- Responsibilities of Receiving Unit
- Review of analytical method and acceptance criteria
- To ascertain the availability of necessary equipment for QC as per the test procedure
- Availability of experienced and adequately trained personnel
- Proper documentation system for recording receipt and testing of samples and collecting data
- Proper execution of the transfer protocol
- Ability to perform the appropriate level of validation of the method
- Ability to produce and get the approval of transfer reports.
Analytical method transfer not only saves time and money for the pharmaceutical unit but also lets it have the benefit of expertise and sophisticated instruments of the receiving laboratory. However, there must be no compromise in the accuracy, authenticity, specificity, and sensitivity of the test.