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 analyses 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 analyses.
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 analyses at the FILAB laboratory
Since the transfer of the method was approved, the FILAB laboratory has been conducting routine soil decontamination analyses 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 studies that may be of interest to you
Piston failure
A piston is a crucial mechanical component in many mechanical devices and engineering systems. Pistons enable various applications, including: Find out moreIndustrial waste
In an ever-changing industrial landscape, many manufacturers encounter material residues in the production of their products. Find out moreOptimization of the coating of a can
One of our clients wants expertise and optimization of the coating used on the cans it uses to market its beverages. Find out moreServices associated with the case study
Laboratory specializing in analysis and expertise for industrial companies
