Analytical Method Transfer
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The documented process of demonstrating that a previously validated analytical method performs equivalently when moved from an originating (sending) laboratory to a receiving laboratory, using a predefined protocol and acceptance criteria — commonly comparative testing, co-validation, or a documented waiver justified by the method’s simplicity or history.
Method transfer is common whenever testing moves across organizational boundaries — a new CDMO or contract lab coming online, a site-to-site transfer within one company, or bringing an in-house method to a new instrument platform. The protocol is written and approved before testing starts, specifying which samples, how many replicates, and what statistical acceptance criteria the receiving lab must meet against the sending lab’s results.
Not every transfer requires full comparative testing: a well-justified transfer waiver may be appropriate for a simple, well-characterized compendial method, while a more complex or novel method typically warrants co-validation or a full comparative study.
- —Confirms an already-validated method performs equivalently at a new (receiving) laboratory
- —Common approaches: comparative testing, co-validation, revalidation, or a documented transfer waiver
- —Protocol and acceptance criteria are approved before testing begins
- —Frequent at CDMO/contract-lab onboarding and site-to-site transfers
USP <1224> Transfer of Analytical Procedures; ICH Q2(R2)
Frequently asked questions
What is Analytical Method Transfer?
The documented process of demonstrating that a previously validated analytical method performs equivalently when moved from an originating (sending) laboratory to a receiving laboratory, using a predefined protocol and acceptance criteria — commonly comparative testing, co-validation, or a documented waiver justified by the method’s simplicity or history.
Which regulations cover Analytical Method Transfer?
USP <1224> Transfer of Analytical Procedures; ICH Q2(R2)