Analytical Technology Transfer Standard

The transfer of validated analytical methods requires that the method performance does not change as a result of this activity.  That is, the same quality of data can be generated in support of product quality at the receiving laboratory as is being generated in the sending laboratory.  The transfer is not intended as a reconfirmation of the entire scope of the validation study.  Rather, it is a supplement to the validation study that demonstrates the reproducibility, or inter-laboratory precision, of the analytical method.  This document encompasses analytical technology transfers within company as well as those between company and external laboratories. 

Standard Requirements

The sending laboratory representative/management responsibilities include but are not limited to

1) evaluating the validation study to ensure compliance with analytical validation standards,

2) providing appropriate documentation pertaining to the method development, validation, post-validation studies, limits, equipment, analytical procedure, and purpose and timing for transfer to the receiving laboratory,

3) providing input into the transfer protocol and report,

4) training the receiving laboratory on the method,

5) performing the transfer study, and

6) communicating and collaborating with the receiving laboratory. 

The receiving laboratory representative/management responsibilities include but are not limited to

1) evaluating the documentation provided by the sending laboratory to identify potential issues and evaluate resources and timing,

2) preparing and approving the transfer protocol and report,

3) completion of training

4) performing the transfer study,

5) initiating appropriate documentation required for routine use of the analytical method, and 6) communicating and collaborating with the sending laboratory.

The QA management responsibilities include ensuring cGMP compliance during the analytical transfer, reviewing and approving the transfer protocol and report and maintaining communication with the laboratories.

Upon identification of the receiving laboratory, the sending laboratory compiles all pertinent information regarding the method/s to be transferred including the validation report, appropriate pre- or post-validation studies, analytical procedure, detailed equipment list, limits laboratory/reference standard information, and the purpose of and timing for transfer completion. This information is provided to the receiving laboratory.

Upon delivery of the method-specific information, the receiving laboratory reviews the information to identify potential issues, to evaluate resource needs, determine training needed, and prepare a transfer timeline. The results of this evaluation are communicated to the sending laboratory.  Issues already resolved should be documented.

A transfer protocol should be prepared using input from both the sending and receiving laboratories. The protocol contains,

1) an assessment of the appropriateness of a comparative study for the method,

2) details of the comparative study, if needed, including an appropriate sample size to demonstrate that a difference can be detected should one exist, acceptance criteria, details of the representative sample/s to be used and the manner of data collection, and

3) timing for completion of the transfer study. 

This protocol is to be approved by both the sending and receiving laboratories as well as QA.

If new equipment is needed in the receiving laboratory, then installation and qualification of the equipment per corporate standards is to be completed prior to generating data for the comparative study.

Necessary training of the receiving laboratory will take place and be documented. A familiarization period allows for the method to be performed as written to ensure requirements of the procedure can be met.

Analytical transfer data generated in each laboratory must be collected as described in the transfer protocol.

Data generated in each laboratory shall be statistically compared, if appropriate, per a transfer protocol and any internal guidelines to demonstrate reproducibility.

A transfer report must be prepared that includes the results of the transfer study, statistical analysis, if appropriate, and a statement of the acceptability of the receiving laboratory to perform the analytical method. Deviations from the transfer protocol must be justified.  Notebook references to raw data must be included.  This report is to be approved by both the sending and receiving laboratories as well as QA.

Written records shall be maintained such that transfer of individual procedures and the historical sequence of subsequent changes can be reconstructed.  These historical records shall be retained according to approved record retention schedules.