Analytical Method development validation transfer

We develop and validate analytical methods required for all stages of clinical trials. After completion we are able to transfer those methods including the scale up support to ensure the method in production scale.

NEW ANALYSIS PROCEDURE, PRACTICALLY APPLICABLE – optimized, cost-effective, certified

The broad range of services offered by Suisse Technology Partners AG covers the entire process of the development,validation and life cycle management activities of suitable analysis methods according to the key principles of current and upcoming ICH guidelines (ICH Q2(R1) Validation of Analytical Procedures and Q2(R2)/Q14) Analytical Procedure Development / Analytical Validation.

Method development

Appropriate analysis methods need to be developed for new products and for the qualitative and quantitative determination of specified impurities or identification 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 assay and purity determination of drug substances and drug products
  • Development of analytical methods for the cleaning validation
  • Creation of complete analysis packages for the monitoring of chemical production processes
  • Development of analytical methods for routine analyses or commercial release  according to customer requirements

Method validation

The validation of analytical methods is required in cGxP regulations and accreditation standards like ICH Q2(R1) or the upcoming Q2(R2)/Q14. The analytical method validation provides the documented proof that an analytical method meets the previously specified requirements in practical use.

Together with the customer, the scope of the method 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.

In summary, our “one-stop” validation services include:

  • Evaluation whether existing analytical procedures meet current requirements for following analytical method validation
  • Evaluation of stability indicaticating properties of the analytical procedure to be validated (see Forced Degration Studies)
  • Life Cycle management of analytical method validation studies and evaluation of the need for revalidation
  • Design of the analytical method validation study for new analytical procedures or existing methods which need to be (re)validated
  • Creation of validation plans
  • Performing measurements, data evaluation and graphical representation
  • Creation of validation reports

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? Or you want to transfer an analytical procedure to Suisse TP for release testing purposes?

Suisse Technology Partner AG 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.

Our streamlined method transfer approach includes:

  • Coordination of the method transfer from the transferring to the receiving laboratory
  • Definition of the method transfer type: Comparative testing, Co-validation, Re-Validation or Partial Validation, Transfer Waiver
  • Overall oversight of transfer planning, documentation, timelines, deviations, changes
  • Gap assessment of analytical capabilities, cGxP status of equipment qualification and training needs in the receiving lab
  • Technical lab and training support for the receiving lab
  • Execution or support of laboratory specific deviations and investigations
  • Creation of method transfer plan and final report

Infrastructure

Suisse TP has a wide range of analytical methods and instruments for the qualitative and quantitative characterization of substance samples.

Besides the organic and inorganic instruments and methods our infrastructure comprises mechanical instruments e.g. SEM.

On our company website you can convince yourself of our extensive infrastructure. Competence Chemistry / Pharma

Do you need validated analytical methods?

Contact me!

Dr. Ute Raab

Head of Pharma & Chemistry, Board Member


Tel: +41 52 551 11 48
Mail: pharma@suisse-tp.ch