Verification of Compendial Methods

1.0 OBJECTIVE

To lay down the procedure for Verification of Compendial Methods

2.0 SCOPE

This SOP is applicable for the verification of Verification of Compendial Methods in Company

3.0 BACKGROUND

NIL

4.0 RESPONSIBILITY

4.1 Scientist – Analytical Research for preparation and execution of Analytical Method verification Protocol and Summary reports.

4.2 Group leader – Analytical Research Department shall review the Analytical Method Verification Protocols and Summary Reports

4.3 Head – Analytical Research and Head – Quality Assurance of their designees to approve the Analytical Method verification Protocol, Summary Reports and ensure compliance.

5.0 PROCEDURE

5.1 The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose[ICH].

5.2 Validation is required for identification tests, Quantitative tests for impurities' content, Limit tests for the control of impurities and Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

5.3 The objective of the analytical procedure should be clearly understood since this will govern the validation characteristics which need to be evaluated. Typical validation characteristics which should be considered are listed below: Accuracy, Precision [Repeatability, Intermediate Precision], Specificity, Detection Limit, Quantitation Limit, Linearity and Range.

5.4 Method Validation is not required for compendial methods, but you need to verify the method.

5.5 Verification is not required for basic compendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test. Examples of basic compendial procedures include, but are not limited to, loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumental methods such as pH measurements.

5.6 The verification process for compendial test procedures is the assessment of whether the procedure can be used for its intended purpose, under the actual conditions of use for a specified drug substance and/or drug product matrix.

5.7 The process of assessing the suitability of a compendial analytical test procedure under the conditions of actual use may or may not require actual laboratory performance of each and every analytical performance characteristic listed in the table.

5.8 The methods such as titrations, chromatographic procedures (related compounds, assay, Limit tests) and Spectroscopic tests etc..

5.9 Based on the Information available at USP <1226>, we are listed the method verification characteristics in the following table.