Verification procedure for Analytical methods

1.0 OBJECTIVE

To lay down the procedure for analytical methods verification for Raw materials and Finished Pharmaceutical products.

2.0 SCOPE

This SOP is applicable for the verification of analytical methods or methodology from compendia including but not limited to USP, BP,EP and JP 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 suitability of analytical procedures must be verified under actual conditions of use.

5.2 Analytical method verification to be performed and the acceptance criteria shall be Established based on the consideration of intended use of the method and applicable specifications.

5.3 Analytical method verification activity and method transfer is required originated at Analytical Research department,

5.4 Based on USP/BP/EP/JP/ICH, the acceptance criteria for verification studies shall be established such that the results meeting the requirements will provide the confidence that the method will perform suitably as intended when apply to the raw materials or drug products etc.,

5.5 Analytical Methodology to be followed for the Analytical method verification assessment shall be performed to which of the validation characteristics required to verify the analytical method.

5.6 The parameters to take up the verification activity for analytical methods mentioned for identification tests by instrument ( by HPLC /UV etc.,) and it is based on the following but not limited to

(a)System suitability

(b) Specificity

5.7 The parameters to take up the verification activity for analytical methods mentioned for Dissolution tests and it is based on the following but not limited to

5.7.1 Dissolution test for IR Products

(a) System Precision

(b) System Suitability

(d) Precision

(e) Batch Analysis

(f) Solution Stability

(g) Suitability of Filter

5.7.2 Dissolution test for DR,ER,PR,MR,SR products

(a) System Precision

(b) System Suitability

(d) Precision

(e) Accuracy ( minimum 1 determination)

(f) Limit of Quantification

(g) Batch Analysis

(h) Solution Stability

(i) Suitability of Filter

5.8 The parameters to take up the verification activity for Compendial analytical methods mentioned for Assay and CU tests and it is based on the following but not limited to

(a) System Precision

(b) System Suitability

(d) Precision

(e) Accuracy ( Mainly recovery minimum 1 determination)

(f) Batch Analysis

(g) Solution Stability

(i) Suitability of Filter

5.9 The parameters to take up the verification activity for Compendial analytical methods mentioned for Related Impurities/Related substances method and it is based on the following but not limited to

(a) System Precision

(b) System Suitability

(d) Precision

(e) Accuracy ( Mainly recovery minimum 1 determination)

(f) Limit of Quantification

(g) Batch Analysis

(h) Solution Stability

(i) Filter Suitability

5.10 The parameters to take up the verification activity for analytical methods mentioned for limit tests ( metals etc.,) and it is based on the following but not limited to

(a) Specificity

(b) Limit of Detection

5.11 Compendial analytical method verification activity to be performed by approved protocol and summary report

6.0 REFERENCES

NIL

7.0 VERSION HISTORY