Analytical Method Validation ICH Guidelines

The International Council 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. 

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