Analytical Method Validation
Valicare knows the requirements for analytical method validation
Analytical methods used for the production and testing of active pharmaceutical ingredients (API) or medicinal products as well as for qualification, validation and purification processes must be validated according to the current regulatory requirements.
Regulatory background
The development and validation of analytical methods for the testing of medicinal products are based on the guidelines ICH Q2(R2) and ICH Q14, which were developed within the framework of the International Council for Harmonization (ICH). The ICH Q14 guideline describes the harmonized requirements for the development of analytical methods. Particular attention is paid to demonstrating the robustness of the method. Another focus is on the principles for facilitating more efficient, science-based and risk-based post-approval change management. The ICH Q2(R2) guideline describes the principles of validation of analytical methods, including validation principles. In particular, specifications for individual analytical methods have been included in the updated version.
The two guidelines were adopted and published by the ICH Assembly in November 2023. The implementation of the guidelines began in March 2024.
Pharmacopoeial methods and system suitability
Depending on the planned application, pharmacopoeial methods can be used after verification and without prior validation, provided that all pharmacopoeial specifications are met. The scope of verification must also be determined based on the planned application and the risks arising for the product and the method and will in part have to be supplemented by individual validation tasks. If the method has already been established in another laboratory, the risk-based method transfer is suitable in this case.
The proof of system suitability is processed as daily standard and secures the analysis carried out but does not replace the validation of the method. Currently, it is rather expected that trend analyses are carried out with the help of the results of the system suitability samples in order to recognize changing conditions as early as possible. In addition, the validity of a validation is no longer considered indefinite, so that revalidations or validation reviews must be carried out at risk-based intervals.
Your analytical method – our experience
Valicare offers detailed training as an introduction to this complex of topic. We advise and support you in the planning, documentation and evaluation of verifications and validations as well as in method transfers and in the preparation of the correspondingly necessary risk analyses. Thanks to the competence and many years of practical experience of our staff in almost all areas of quality control, we are able to support you in a wide range of analytical methods, from small molecule drugs to advanced therapy medicinal products (ATMPs). All common chemical and biochemical analysis and coupling techniques as well as cell and molecular biological analysis and functional assays have been successfully applied by our experts in practice, which allows us to fully support you in the preparation of the required documentation, the planning of the experiments and the interpretation of the analytical data.
We offer support for analysis and coupling techniques:
- IR, UV/Vis, NIR, Raman, GC, CE, HPLC, MS, MS/MS, ELSD, titration, XRD, NMR, gel electrophoresis.
- Microbial contamination (TAMC/TYMC), absence of certain germs, endotoxin concentration determination
We offer support for the following cell and molecular biological analysis and functional assays:
- Gene or protein expression analysis, hematological-immunological flow cytometry, viability, phagocytosis, cell-based functional tests (stimulation, inhibition, toxicity) with different endpoints.
Support in the development and establishment of GMP-compliant analytical methods and in method validation in the context of manufacturing medical devices round off our range of services in this field.
Please do not hesitate to contact us about this topic.
Here you will find the service summarized in a brochure:
