Process Laboratory: securing your analytical methods

Bringing a product to market, optimizing a process, or managing a non-conformity requires analytical methods that are robust, suited to the matrix, and aligned with your quality objectives. In practice, manufacturers often have to deal with tight deadlines, complex matrices, high documentation requirements, and increasing regulatory expectations. An insufficiently characterized method can lead to non-reproducible results, lengthy investigations, release delays, or difficulties during a site transfer. In this context, a Process Laboratory capable of structuring the development, validation, and use of tests becomes a concrete driver of performance. Method reliability helps secure the assay of active substances, impurity screening, stability testing, cleaning residue analysis, elemental impurity assessment, and support for process validation.

Method development is not limited to choosing an instrument. It involves understanding the product, the process, possible interferences, and acceptance criteria. FILAB designs tailor-made methods for compound assay, impurity screening, trace analysis, stability testing, and contaminant evaluation. Validation can be carried out according to the applicable standards, notably ICH Q2 or USP 233, in order to demonstrate the method's performance under its actual conditions of use.

The reliability of a method also depends on how well the analytical objective matches the instrumental resources. FILAB uses liquid chromatography techniques such as LC-UV, LC-MS/MS, LC-QTOF/MS, LC-RI, LC-CAD, and LC-ELSD, as well as gas chromatography with GC-MS, GC-FID, and HS-GC/MS. The laboratory also relies on ICP-AES, ICP-MS, ICP-MS/MS, and ion chromatography to address assay, identification, impurity profiling, or trace contaminant screening issues.

Choosing FILAB means relying on an independent laboratory, ISO 17025 accredited by COFRAC, capable of working on projects with major technical and regulatory stakes. The teams mobilize human, instrumental, and documentary resources adapted to the client's business sector, with a results-driven approach: deliver a relevant method, demonstrate its performance, and provide data that can be used for industrial decision-making. The laboratory is also recognized under the CIR scheme, which can be an asset for certain R&D projects via our Laboratoire Agree Cir page.

FILAB supports manufacturers across all sectors in managing their analytical methods, with an approach based on technical relevance, traceability, and adaptation to the real need. The laboratory handles the different stages of the project: feasibility study, technique selection, method development, parameter optimization, analytical validation, and then transfer to the client site when necessary. This approach applies equally to R&D projects and to industrialization, quality support, failure investigation, or regulatory compliance needs. The work is carried out within a COFRAC-accredited ISO 17025 framework, with expertise available for issues such as ICH Q2, USP 233, ICH Q3D, ISO 19227, ISO 10993, or ISO 13779-3.

This expertise also extends to R&D support and process validation needs: cleaning residues according to ISO 19227, elemental impurities according to ICH Q3D, biocompatibility-related analysis, powder characterization, validation of chemical treatments such as passivation or anodization, and investigations following non-conformities. For complementary morphological or surface examinations, it may be relevant to rely on our expertise in Laboratoire Analyse Meb or Laboratoire analysis Met.

These technical resources are particularly useful for the assay of active ingredients, quantification of elemental impurities, heavy metal analysis, purity control of raw materials or formulations, and assessment of organic, inorganic, or particulate cleaning residues. They also make it possible to address specific needs such as nanoparticle characterization, metal alloy analysis, or support for dedicated standards such as Laboratoire Analyse Iso 21392.

Outsourcing the management of your analytical methods allows you to focus your internal resources on your production, quality, or development priorities. You benefit from a technical contact who can speed up testing, reduce methodological uncertainties, objectify a non-conformity, and prepare a controlled method transfer. Depending on your needs, this approach can be complemented by targeted investigations, for example in Analyse Inclusion Laboratoire to further investigate certain material failures.

To get started effectively, it is important to formalize the analytical need, specify the matrix, the compounds sought, the expected thresholds, and the regulatory context. The next step is to choose the instrumental strategy, develop the method, validate its performance, and then, if necessary, organize its transfer to your site. This structured approach is suitable for R&D projects, process optimization, quality control, failure analysis, or compliance work.