Validaciones de métodos analíticos

The analytical method validation is the process that lead and master the study and analysis required to determine if the analytical method accomplish or not the requirements.

According to the USP guideline <1225>: ¨… Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications…¨

The analytical methods revalidation is a must every time a revised analytical procedure is submitted to the USP for approval and when a general method already established is going to be used with a new raw material or product.

In accordance with the USP guideline <1225> Validation of compendial procedures, ICH Validation of analytical procedures: Text and methodology Q2 (R1), Qualipharma carries out validation of the analytical methods to ensure its reliability, feasibility and adequacy, and therefore guarantee the quality of the products, the accomplishment of the existing regulations and the optimization of the manufacturing and production process.

Qualipharma can support you on the validation of your analytical methods.

The main objective of the validation is to provide general guidelines for monitoring process parameters, to generate accurate data and to release the finished products or formulations, APIs, raw materials while using the suitable analytical methods that guarantee the reliability and accuracy of the process.

Typical Analytical characteristics used in method validation are:

  • Accuracy
  • Precision
  • Specificity
  • Detection Limit
  • Quantitation Limit
  • Linearity
  • Range
  • Robustness

There are cases where a revalidation or a partial validation of the analytical method will suffice, for example when minor modifications in established procedures, changes in the APIs synthesis, changes in the product composition and modifications in analytical methods.

The level or scope of the revalidation depends on the nature of the change; therefore, it is a service that Qualipharma customizes depending on every client request and needs.

  • Processes based on scientific knowledge and risk assessment
  • We provide constant support with the updated regulatory requirements and applicable regulations
  • Project involvement