procedure for Analyst Qualification

1.0 OBJECTIVE

1.1 To describe a procedure for operating, procedure for Analyst Qualification.
2.0 SCOPE
2.1 This procedure is applicable to the Quality control department
3.0 RESPONSIBILITY
3.1 Officer/Executive – QC
4.0 ACCOUNTABILITY

4.1 Head – QC
5.0 PROCEDURE

5.1 QC Head shall identify approved Raw Material and Finish Product and prepare a list for chemist validation.

5.2 QC Head shall keep the record of Material /Product Name, Batch No., A.R. No, Code No. and analytical value of sample along with acceptance limit.

5.3 QC Head shall assign appropriate code no. to each sample identified for qualification.

5.4 QC Head shall give sample for analysis appropriately coded in poly bags/ glass vials to Analyst.

5.5 QC Head shall provide detail Standard Test Procedure to Analyst.

5.6 QC Head shall evaluate the Analyst either one or more, in following test of analysis.

5.7 Assay (Analysis to be carried out in triplicate).

5.8 LOD/Water content (Analysis to be carried out in triplicate).

5.9 pH/SOR (Analysis to be carried out in triplicate).

5.10 Microbiology.

5.11 QC Head shall evaluate the Analyst for one or more of the following analytical method.

5.12 HPLC.

5.13 UV-Visible Spectrophotometer.

5.14 Titration.

5.15 QC Head shall evaluate the skill of the Analyst in terms of its precision to perform the tests and GLP followed by the Analyst.

5.16 The skill to perform tests by Analyst shall be considered satisfactory if the results reported by the Analyst are within the acceptable limits as per Format

5.17 The Analyst complies with GLP if the qualification results are within acceptance limit.

5.18 Document the result as per requirement.
5.19 In case of assay for Raw material and Finished Product, compare all three results with previous Results and find out RSD of all four results.

The limit for RSD shall not be more than 1% for Raw Material and not more than 2% for Finished Product.

5.21 In case of IR analysis all three spectra shall match with Reference Spectra.

5.22 For Qualification of Microbiologist, evaluate the microbiologist w.r.t practices followed in the respective area like carrying out Microbiological Limit Test,

Preparation of Culture, and Settle Plate etc.

5.23 Qualify each new Analyst with in three months of the area of work given to them.

5.24 Keep the details like calculations, chromatograms, and strip chart along with comments of department head in training

file to be maintained separately for each Analyst.

5.25 In case of Analyst found not qualified, re-train the Analyst and do not allot subjected work until he or she is qualified.

5.26 Maintain records related to Training /Re-training and Re-qualification in training file.

5.27 Prepare the final report as per Format

6.0 TRAINING
6.1 Trainer: – Head of Quality Control.

6.2 Trainee: – Quality Control Person.

6.3 Period: – One hour or as per required.

7.0 DISTRIBUTION

7.1 One set of Master copy & control copy submit the QA department.

8.0 ENCLOSURES
Qualification of analyst
Analyst qualification data sheet
9.0 ABBREVIATIONS
9.1 QC : Quality Control
9.2 QA : Quality Assurance
9.3 QCA : Quality Control Analytical
9.4 SOP : Standard Operating Procedure
9.5 SOR : Specific optical Rotation
9.6 No. : Number

9.7 UV Ultraviolet

9.8 GLP Good Laboratory Practice

9.9 A.R. No. Analytical Report Number

9.10 RSD Relative Standard Deviation

9.11 USP United States Pharmacopoeia

9.12 w.r.t. With respect to

9.13 HPLC High Performance Liquid Chromatography

9.14 LOD Loss on drying