The International Committee on Harmonization makes ICH Guidelines for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH’s main goal is to provide uniform standards for pharmaceuticals for technical requirements. The pharma industry and regulatory authorities create these guidelines.
ICH Guidelines are essential to ensure safe, top-quality, and effective medicines are registered and manufactured efficiently. Regulatory authorities adopt these guidelines all over the world.
Analytical method validation
Validation of analytical methods can be subjected to the following analytical procedures.
Quantitative test for the content’s impurities
Limit tests for impurities control
Identification tests
Quantitative tests of active group in drug substance samples or other chosen drug product components
Identification tests are aimed to ensure the analyte’s identity in a sample. It can be done through the comparison of sample property to a reference standard.
Testing for impurities can be a limit test or a quantitative test for the sample’s impurity. The test aims to reflect the sample’s purity characteristics accurately.
Assay methods are aimed to measure the existing analyte in a specific sample.
Validation Characteristics for Analytical Methods
The following are the validation characteristics needed to be evaluated in analytical procedures.
Precision
Precision presents the quality of agreement in a group of measurements from different sampling of a similar homogeneous sample of prescribed conditions. This characteristic can be considered in three levels: intermediate precision, repeatability, and reproducibility.
Repeatability – this precision signifies under similar operating conditions within a short time. It is also called intra-assay precision.
Intermediate precision – it presents laboratories variations: various equipment, days, analysts, and more.
Reproducibility – it is the precision of laboratories.
Accuracy
The analytical method’s accuracy presents the closeness of agreement between the value accepted as a reference value, conventional true value, and the value found.
Detection limit
It is considered as the lowest analyte amount in a sample that can be identified but not necessarily quantitative in the exact value.
Specificity
It is the assessment of unequivocally the presented analyte of components. It may include degradants, impurities, matrices, and more.
Quantitation limit
It is characterized by an analytical method is the lowest analyte amount in a sample. It can be identified quantitatively using suitable accuracy and precision. In addition, it is the quantitative assays parameter for those compounds with low levels in given matrices.
Range
The range is the interval between the lower and upper concentration analyte amount in a sample. It can demonstrate that the analytical method comes with a suitable accuracy, precision, and linearity.
Linearity
It is the ability to get test results proportional to analyte’s concentration in a sample.
Conclusion
Analytical method validation is important for ICH guidelines. The characteristics mentioned above are essential for the validation of analytical procedures. With ICH guidelines, potential risks can be identified and prevented to harm people.
ICH guidelines are crucial for the manufacturing of top-quality medicines. With this, the products are registered and created efficiently. So, the products will be delivered in the best possible quality that will ensure the safety and efficiency of medicines.
Quo omnis forensibus ei. Integre adversarium sea cu, eos viris propriae noluisse no. Nam te odio aeque, vis probatus percipitur signiferumque et.
Affert intellegebat per id, phaedrum recusabo vituperata ad duo. In nam nulla impedit petentium.
Id mel wisi timeam interpretaris. Ad maiorum partiendo pri, pro erat singulis omittantur ex. Pro in minim phaedrum sententiae, ne mucius forensibus mnesarchum qui, id dicat molestie verterem has. Mea id delectus erroribus, vix ceteros accusata cu. Nulla commodo ornatus mea in, ea usu fugit epicurei.