Development and validation of analysis methods
We develop and validate analytical methods that are required for all phases of clinical trials.
After completion, we are able to carry out release analyses. We transfer these methods at the customer’s request.
NEW ANALYSIS PROCESSES, PRACTICALLY APPLICABLE – optimized, precise, certified
Our broad range of services covers the complete process of development, validation and life cycle management activities. The analytical methods are in line with the basic principles of the current and future ICH guidelines(Q2(R2)/Q14) Analytical Procedure Development / Analytical Validation.
Method development
Suitable analytical methods must be developed for new products and for the qualitative and quantitative determination of specified impurities or for the identification of unknown substances. Experienced analysts develop optimized, precise and robust analysis methods.
Here are some examples of typical applications:
- Development of release-relevant analytical methods for assay and purity determination of drugs and drug products
- Development of analytical methods for cleaning validation
- Creation of complete analysis packages for the monitoring of chemical production processes
- Development of analytical methods for routine analyses or for commercial release according to customer requirements
Methods Validation
The validation of analytical methods is prescribed in cGxP regulations and accreditation standards such as ICH Q2(R2)/Q14. The validation of analytical methods provides documented proof that an analytical method fulfills the previously defined requirements in practical use.
The scope of the method validation and the acceptance criteria are defined in a validation protocol together with the customer. The experimental work is carried out by qualified employees and the results are summarized in a validation report.
To summarize, our validation services include the following:
- Evaluation of whether existing analytical procedures meet the current requirements for the subsequent validation of analytical methods
- Evaluation of the stability-indicating properties of the analytical method to be validated (see Forced Degration Studies)
- Lifecycle management of studies for the validation of analytical methods and assessment of the need for revalidation
- Design for the validation of analytical methods for new analytical procedures or existing methods that need to be revalidated
- Creation of validation plans
- Carrying out measurements, data evaluation and graphical representation
- Creation of validation reports
Transfer methods
Would you like to transfer an analysis method developed and validated by Suisse TP to another laboratory? Or would you like to transfer an analytical method to us for release testing?
We take care of the entire method transfer for our customers in accordance with an agreed transfer plan and in compliance with the applicable regulations.
A risk analysis is used to evaluate existing differences between the Suisse TP laboratories and the customer laboratories. Their probable influence on the validity of the process is analyzed. The scope of the transfer work and the required acceptance criteria are determined on the basis of the risk analysis and described in the transfer plan.
The method transfer order is completed with the preparation of a transfer report.
Our lean approach to method transfer includes:
- Coordination of method transfer from the supplying to the receiving laboratory
- Definition of the type of method transfer: comparative testing, co-validation, re-validation or partial validation
- Project management for all transfer activities (e.g. planning, reporting, deadlines, deviations, changes)
- Assessment of analytical capabilities, cGxP status of equipment qualification and training needs in the receiving laboratory
- Technical laboratory and training support for the reception laboratory
- Implementation or support of laboratory-specific deviations and investigations
- Preparation of the method transfer plan and the final report
