| SOP for Validation of Analyst |
1.0 OBJECTIVE To lay down the procedure for the validation of analyst, to ensure the competency level of the analyst. 2.0 SCOPE This procedure is applicable for procedure for the validation of analyst to ensure the competency level of the analyst in quality control department. 3.0 RESPONSIBILITY QC – Officers/Executive/Senior Executive/Asst. Manager 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 The Supervisor QC shall select samples for analyst validation. 5.2 For the qualification of any analyst, first fill the analyst assessment form as per format no. XXX. 5.3 The analyst shall undergo validation for either one or more of analytical parameters. 5.4 The analysis for analyst qualification shall be done for a control sample batch which is already approved. We will Use Vendor’s Approved material for analyst qualification in first Phase. 5.5 The necessary information required for analysis of samples shall be disclosed to the analyst to be validated. 5.6 The analyst to be validated perform one of the following test for validation: 5.6.1 Assay (by HPLC or UV or potentiometrically) 5.6.2 Dissolution (by HPLC or UV) 5.6.3 Related substances (by HPLC) 5.6.4 Infrared Spectrum 5.6.5 Auto Titrator 5.6.6 Karl Fischer Titrator 5.7 The analyst to be validated shall perform 6 preparations for IR, Auto Titrator, Karl fisher and assay by UV / HPLC. The average of the six preparations shall be taken. The percentage variation of the average from the initial results shall not be more than 2.0%. 5.8 For dissolution (single batch), the percentage variation of average from initial results shall not be more than 5.0. 5.9 For related substances test (single batch), the percentage variation from initial results are given in below: Acceptance criteria Related Substances Single individual impurity Percentage variation from initial results Less than 0.2 % ± 0.1% Individual Impurity up to 0.5% ± 0.2% Up to 1.0% ± 0.3% More than 1.0% ± 0.5% 5.10 All the results shall be found within specification limits. 5.11 Degradant products shall be justified on the basis of stability data, if percentage variation found beyond limit. 5.12 After completion of analysis, fill the details and results in analyst qualification protocol/ report as per format no. XXX. 5.13 The capability to perform tests by analyst shall be considered satisfactory if the results reported by the analyst are within the acceptable limits as per the limits mentioned above, and satisfactory entries in the respective documents. 5.14 The details like calculations and chromatograms along with comments of QA Head; QC Head shall be filed in analyst validation protocol/ report. 5.15 The supervisor shall give the training to the fresher candidates for physical parameters like friability, disintegration test, diameter, thickness, hardness, LOD etc. And before allocation to instrumental analysis, the analyst shall be qualified as per above procedure. 5.16 Revalidation criteria: 5.16.1 If analyst fails in validation, he / she shall be re-trained in his respective area and he/ she shall undergo successful validation prior to go for routine analysis. 6.0 ABBREVIATIONS SOP – Standard Operating Procedure No. – Number QA – Quality assurance QC – Quality control No. – Number LOD – Loss of drying |
