State-of-the-art regulation-compliant validation of analytical methods

We validate your analytical methods for the production and testing of active pharmaceutical ingredients (API) or medicinal products, as well as for qualification, validation, and cleaning processes.

Regulatory background

Analytical procedures are validated according to the ICH Q2(R2) regulations, which recently updated with method specific requirements. The guideline provides the framework, which must be followed and filled by the user according to the current state of science and technology, where required. The new guideline ICH Q14 is linked to the update of ICH Q2 (R2). It adds the concept of an enhanced approach to demonstrate process understanding and it provides guidance on life cycle consideration in analytical method development.

This set of rules is to be understood as a binding framework for the validation of analytical methods. However, it must be further specified and interpreted based on the type of testing (identity, content, purity/impurities) and the analytical method. Due to the complexity of diverse and newly developed methods, method validation requires a great deal of method-specific expertise as well as careful consideration of risk management.

Depending on the intended use of the method, the specificity/selectivity, working range, linearity, precision, accuracy as well as detection and detection limits of the method must be determined. Moreover, acceptance criteria must be defined in advance of the validation and given limit values must be complied with.

Pharmacopeial methods and system suitability

Depending on the planned application, pharmacopeial methods can be used after verification and without prior validation, provided that all pharmacopeial specifications are met. The scope of verification must be determined on the basis of the planned application and the risks arising for both product and method and must partly be supplemented by individual validation tasks. If the method has already been established in another laboratory, the risk-based method transfer applies.

The proof of system suitability is processed as a daily standard and secures the analysis. However, it does not replace the validation of the method. Currently, trend analyses are expected based on the results of the system suitability samples in order to recognize changing conditions as early as possible. In addition, a validation is no longer considered indefinitely valid, 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 topic. We advise and support you in planning, documenting and evaluating verifications and validations as well as in transferring methods and preparing the corresponding risk analysis. Thanks to the expertise and many years of practical experience of our staff in almost all areas of quality control, we can support you in a wide range of analytical methods, from small molecule drugs to advanced therapy medicinal products (ATMPs). Our experts have applied all common chemical and biochemical analysis and coupling techniques as well as cell and molecular biological analysis and functional assays in practice, which enables them to fully support you in preparing of the required documentation, planning the experiments, and interpreting the analytical data.

We offer support for the following 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 developing and establishing GMP-compliant analytical methods and in method validation in the context of manufacturing medical devices round off our range of services.

The following brochure provides a summary of our services in this area. Please do not hesitate to contact us.