Transfer of a validated method to a receiving laboratory is a GMP required activity that qualifies a receiving laboratory to perform the method. The method transfer process is intended to ensure that the receiving laboratory can reproduce the method accurately and precisely. The primary activities involved in method transfer include protocol preparation, documented training, comparative testing (at sending and receiving laboratories to confirm equivalency of results to predetermined acceptance criteria) and report generation including a laboratory qualification statement. The FDA has issued guidance on method transfer in the document entitled “Analytical Procedures and Methods Validation for Drugs and Biologics” and the USP has issued guidance in <1224> Transfer of Analytical Procedures.
Jordi Labs can provide support for all key steps of the method transfer process including:
- Consultation on study design and sample selection
- Transfer protocol writing
- Comparative testing
- Final method transfer report generation
Jordi Labs provides more than 60 different analytical techniques. This broad knowledge of analytical chemistry ensures easier method transfer. In addition, Jordi’s extensive analytical chemistry and method validation experience to USP, FDA and ICH guidance allows for a valid risk-based assessment of the pertinent validation parameters and creation of a thorough method transfer protocol. We can rapidly execute method feasibility assessments to ensure a smooth method transfer. Types of method transfers which Jordi Labs can support include:
- Comparative Testing – Analysis of a predetermined number of samples of the same lot by both the sending and the receiving laboratories
- Covalidation – Jordi Labs can serve as part of the initial method validation and the evaluation of interlaboratory precision
- Revalidation – Validation or revalidation can be performed to qualify Jordi Labs to perform the method with a focus on those validation parameters anticipated to be potentially affected by the transfer
- Transfer Waiver – In certain instances, it is permissible to exclude a formal transfer process including when the method is a USP–NF method and is unchanged or the analytical procedure is the same or very similar to a previously qualified method already in use
Collaboration between Jordi Labs and the transferring laboratory is key to a successful method transfer. To aid this process we recommend that the sending laboratory provide:
- A copy of the method SOP
- A copy of the existing method validation document
- Information to aid co-development of a risk-based approach to method transfer based on the sending lab’s experience with the method
We welcome the opportunity to work with our clients to assure a smooth transfer. You can reach us here.