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Pharma & Chemistry

Method Development, Validation and Transfer

 

Analytical Method Development, Validation and Transfer

new analysis procedure, practically applicable

 

You want to launch a new product on the market and need validated analytical methods, which are required in the context of an authorization and registration obligation?

You need to analytically control a synthesis route or need analytical methods to characterize your product?

The broad range of services offered by Suisse Technology Partners Ltd. covers the entire process from the development of suitable analysis methods and their validation, together with the preparation of the validation report, through to the complete implementation of a method transfer that conforms to approval requirements..


Method development

Appropriate analysis methods need to be developed for new products and for the qualitative and quantitative determination of unknown substances. The experienced analysts of Suisse TP develop optimized and therefore cost-effective analysis methods.

Here are a few examples of typical applications:

  • Development of release-relevant analysis methods for APIs
  • Development of analytical methods for the cleaning validation
  • Creation of complete analysis packages for the monitoring of chemical production processes
  • Development of routine analyses according to customer requirements

Method Validation

The validation of analytical methods is required in GMP regulations and accreditation standards. Validation provides documented proof that an analytical method meets the previously specified requirements (acceptance criteria) reproducibly in practical use. Together with the customer, the scope of validation and the acceptance criteria are defined in a validation protocol. The experimental work is then carried out by qualified employees of Suisse TP and the results are summarized in a validation report.

Method transfer

You want to carry out an analysis method developed and validated with us in your own laboratory or in the laboratory of one of your partners?

Suisse TP takes over the complete implementation of the method transfer for its customers according to a coordinated transfer plan and in compliance with the applicable regulations.

With the help of a risk analysis, existing differences between the Suisse TP laboratories and the customer laboratories as well as their probable influence on the validity of the process can be analyzed and evaluated. From this risk analysis, the scope of the transfer work and the acceptance criteria to be met are derived and described in the transfer plan.

The method transfer order is completed with the creation of a transfer report.


Contact


Dr. Ute Raab
pharma@suisse-tp.ch +41 52 551 1148