Analytical Method development validation transfer
We develop and validate analytical methods required for all stages of clinical trials.
On completion we are able to transfer those methods including 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. Analysis methods are in accordance 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
- Execution of measurements, data evaluation and graphical representation
- Creation of validation reports
Method transfer
You want to transfer an analysis method developed and validated by Suisse TP to another laboratory? 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 evaluated. Their probable influence on the validity of the process is analyzed. The scope of the transfer work and the required acceptance criteria are based on the risk analysis 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
- Project Management of all transfer activities (e.g. planning, reporting, 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.
In addition to instruments and methods for organic and inorganic analyses, our analytical possibilities also include mechanical instruments e.g. SEM.
Visit our company website to discover our extensive infrastructure. Competence Chemistry / Pharma
