| Title: Transfer of Analytical Methods | |||||
| Guidance Number: 92 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Transfer of Analytical Methods
Introduction
This document provides guidance for establishing a documented process for the transfer of analytical methods, microbiological, and/or bioanalytical methods.
1. Responsibilities of the Transferring Laboratory Qualified Personnel include:
- Identify the qualified personnel to lead, execute, and complete the transfer activities. If a facilitator or 3rd laboratory is used, then their responsibilities should also be identified;
- Provide method specific information to the Receiving Laboratory qualified personnel;
- Provide method specific training and support to Receiving Laboratory qualified personnel, as applicable;
- Generate, review, and approve transfer documents;
- Provide data that have been reviewed and approved, if required;
- Initiate and support investigations as required; and
- Ensure that the Laboratory Qualification Memo is reviewed and approved by the Site Quality Team.
2. Responsibilities of the Receiving Laboratory Qualified Personnel include:
- Identify qualified personnel to lead, execute, and complete the transfer activities;
- Review the method specific information provided by the Transferring Laboratory qualified personnel;
- Ensure the instruments and equipment are available and suitable for use;
- Review and approve transfer documents;
- Ensure data have been reviewed and approved;
- Support investigations, when required;
- Ensure that the Transferring and Receiving Laboratories have approved the Laboratory Qualification Memo prior to using the methods for routine sample analysis.
3. Acceptable Modes of Transfer include, but are not limited to:
- No transfer activity (e.g., compendial methods for excipient appearance testing);
- Method Overview; and
- Comparative Testing.
For Comparative Testing, results generated by the Receiving Laboratory may be compared with historical data, or to data that have been generated in parallel by the Transferring Laboratory.
Validation of methods does not require any additional transfer documentation.
4. The Transfer Plan Document(s) should detail the following:
- The test(s) to be transferred,
- The modes of transfer,
- The justification for the modes of transfer selected, and
- Pre-determined acceptance criteria.
Both quantitative and qualitative methods should be assessed to determine if transfer of the methods is required. The complexity of the method should also be considered.
5. The Need for a Transfer Plan Amendment may arise during execution of the Transfer Plan. The amendment should provide a description and rationale for each change and should be approved by qualified personnel at the participating laboratories prior to implementation.
6. If Acceptance Criteria are Not Met, qualified personnel at the participating laboratories should conduct an investigation to identify the potential cause(s) of the failure.
If the root cause for the failure is attributed to the testing laboratories or the transfer strategy, additional testing may be necessary and documented in a Contingency Testing Plan.
If the cause for the failure is attributed to the capabilities of the method, Subject Matter Expert(s) (SME) should be identified and assigned to provide timely evaluation and resolution. Transfer work should be suspended until any necessary changes are made.
If the cause for failure cannot be attributed, a review and an assessment of the results should be made using the data generated during the transfer, the corresponding investigation, and any other information pertaining to the history and performance of the method. This evaluation is used to determine if additional testing is required or, under certain limited circumstances, to reassess the original acceptance criteria.
A justification for the acceptance of data that do not meet the acceptance criteria should be documented in the Laboratory Qualification Memo and a description of the investigation should be included.
If the qualified personnel at the participating laboratories determine that the transfer effort is to be discontinued, the reason for this determination should be documented and approved by the qualified personnel at the Transferring and Receiving Laboratories.
7. If Additional Testing is Necessary, qualified personnel at the Transferring and Receiving Laboratories should approve a Contingency Testing Plan prior to implementation of the additional testing. The Contingency Testing Plan should include the following:
- References to any previous transfer plan or amendments;
- A summary of results from the Transfer Plan, and the subsequent investigation; and
- Documented rationale for the revised testing strategy or acceptance criteria.
8. Following a Successful Transfer, the qualified personnel at the Transferring and Receiving Laboratories and a Site Quality Team should approve the Laboratory Qualification Memo. Once the Laboratory Qualification Memo has been approved, the Receiving Laboratory is considered qualified to perform the transferred methods.
If the mode of transfer is “No Transfer Activity”; then a Laboratory Qualification Memo is not required.