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Robust process analytical methods for industrial practice and their validation

Objective

The problem of the agreement between analytical results and their mutual recognition (for checking product specifications) is a problem which concerns everybody who is involved in a buyer-supplier relationship. This is a problem for industry and for the national and international bodies. The quality of the analytical results is not always optimal and the industry would welcome cost-effective improvements. This can be achieved by the introduction of chemometric techniques in industrial analytical practice.

The main objectives of the project are
- proposing tools for method validation in an industrial context that have been tried and agreed upon by major European industries and thereby assist European standardization in those matters.
- advancing the status of method validation in (multivariate) process analytical chemical methods.
The development of the GSMV, the SP and the general tools is proceeding according to plan. Several of the already prepared protocols and tools are now being evaluated, tested and validated by the different partners.
A general strategy for method validation (GSMV) consisting of a set of good practice guides, accompanied by software will be developed. This involves the validation of analysis methods based on univariate as well as on multivariate calibration.
To be able to develop the GSMV it is necessary to study a sufficiently large number of specific packages (SP) for specific instrumental methods and/or applications. There will be 7 SP about e.g. chromatography, capillary electrophoresis, inductively coupled plasma, near infrared spectroscopy and multi-sensor arrays. There is also a need for the development of new or adapted general tools (mathematical, statistical, informatics) to be included in the GSMV.
The GSMV is the responsibility of the whole project team but is coordinated by one of the university partners (the coordinating university). The industry partners are responsible for most of the SP and the university partners for the general tools.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

VRIJE UNIVERSITEIT BRUSSEL
Address
101,Laarbeeklaan 103
1090 Bruxelles
Belgium

Participants (7)

ELF-Aquitaine
France
Address
Grl Lacq La Coupole
64170 Artix
Pfizer Ltd
United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Rhône-Poulenc Industrialisation SA
France
Address
24,Avenue Jean Jaurès
69153 Décines-charpieu
Sandoz Pharma AG
Switzerland
Address
35,Lichtstraße
4002 Basel
UNILEVER NEDERLAND BV
Netherlands
Address
120,Olivier Van Noortlaan 120
3133 AT Vlaardingen
Universit degli Studi di Genova
Italy
Address
Via Brigata Salerno (Ponte)
16147 Genova
Universitat Rovira i Virgili
Spain
Address
1,Plaça Imperial Tarraco 1
43005 Tarragona