How FILAB helped one of its clients transfer their API dosing method to wastewater?
As part of the rehabilitation of several of its industrial sites, the client (a pharmaceutical group) must closely monitor the decontamination of its soil and water from active pharmaceutical ingredients (APIs).
For several years, the client had been carrying out these analysis in-house, using established and validated methods. Following a reorganization, they called on an external laboratory, FILAB, to transfer the methods used and continue monitoring the process, under the same quality conditions as those that had been validated.
Our client's internal laboratory therefore sent us the method so that they could eventually completely outsource the analysis of APIs in soil.
This case study aims to understand why method transfer is crucial in carrying out decontamination analysis.
The transfer of decontamination analysis methods
What is an analytical method transfer?
Firstly, an analytical method transfer is a process that involves transferring a previously validated analytical method from a sending laboratory to a receiving laboratory. It also involves ensuring that the method is properly understood and applied in the receiving laboratory.
Validation of the transfer of our client's method to the laboratory
The client provided three wastewater analysis methods to be transferred and used to perform the cross-checks required for transfer validation.
Following a series of tests using methods defined by our client, the FILAB laboratory was authorized to take over its client's activity using three different methods. The equivalence of the results obtained by FILAB and its client was proven.
Launch of routine analysis at the FILAB laboratory
Since the transfer of the method was approved, the FILAB laboratory has been conducting routine soil decontamination analysis for its client on a quarterly basis.
Why FILAB?
Whether from your laboratory or to your laboratory, FILAB applies customized protocols according to your analytical method transfer needs. From specifications to on-site analyst training and the drafting of clear and effective protocols in accordance with regulatory standards, we support our clients every step of the way.
The FILAB laboratory is COFRAC ISO 17025 accredited and works in accordance with GMP. Our specialized doctors and engineers are dedicated to your project from start to finish and are available at any time to answer your questions. We guarantee the quality and reliability of our results and offer you sustainable solutions.
FILAB provides you with its high-level expertise and analytical resources to offer you analytical method development and analytical validation services using GCMS, ICP, XRD, FTIR, DSC, CLI, and more.
Finally, the FILAB laboratory is an approved Training Organization (CIR) and therefore offers you personalized training courses.
Other case studies you may be interested in
Yellowing of silicone
Silicones are now widely used in various fields thanks to their remarkable physical and chemical properties, such as excellent thermal stability, high resistance to oxidation and hydrolysis, and excellent gas permeability. Learn more +ATG kinetics: simulation of PVC part aging
One of our customers wants to evaluate the thermal behavior of 3D-printed parts. Learn more +Services related to the case study
Laboratory specializing in analysis and expertise for industrial companies
Contact us
Our services are reserved for professionals.
Frequently asked questions
What is an analytical method transfer between two laboratories?
An analytical method transfer aims to demonstrate that a receiving laboratory has mastered a method already implemented by a transferring laboratory. It is based on a protocol and acceptance criteria defined in advance. In this study, a pharmaceutical group commissioned FILAB to transfer three methods in order to continue its analytical monitoring following a reorganization.
Why transfer an assay method for pharmaceutical active ingredients?
Method transfer makes it possible to continue analytical monitoring in a new laboratory with verified performance. In the case presented, the client needed to continue monitoring pharmaceutical active ingredients as part of the rehabilitation of industrial sites. The objective was to entrust the analysis to FILAB while maintaining control over the established methods.
How can the success of an analytical method transfer be verified?
Success is verified through tests defined in a transfer protocol and by reviewing the results against agreed criteria. In this study, cross-testing between the client’s laboratory and FILAB demonstrated the expected equivalence of results for three methods. This step preceded their routine use.
What information should be prepared when outsourcing an analytical method?
An actionable description of the method, the relevant matrices, expected performance, and acceptance criteria for the transfer must be provided. Sample preparation procedures and analytical conditions must also be specified. In this study, the originating laboratory provided the methods required to organize comparative testing with FILAB.
What happens after method transfer validation?
Once the transfer has been validated, the receiving laboratory can perform routine analysis according to the arrangements agreed with the client. In the study presented, FILAB resumed quarterly monitoring. The scope of the matrices, testing frequency, and monitoring conditions must remain consistent with the methods actually transferred and the project’s requirements.