- OBJECTIVE
1.1 To lay down a procedure for training and a mechanism to evaluate a chemist on General Analytical techniques.
2. RESPONSIBILITY
2.1 Personnel who are knowledgeable with the subject virtue of their qualification and experience, to train the analyst as required.
- Head – Quality Control – To ensure the compliance of SOP.
- PROCEDURE
- All the analyst undertaking any analysis shall undergo training and qualify on relevant Standard Operating Procedures (SOPs), and General analytical techniques. The general analytical techniques along with acceptance criteria on which the analyst are to be trained are listed in Annexure – 1.
- The training on analytical techniques shall be carried out under the supervision of the senior executive or a analyst already trained on that technique, by following the Standard Test Procedure / Standard Operating Procedure and using already approved product / material as test sample.
- To qualify on the analytical technique the analyst shall perform the test. The results shall be comparable with the results already reported and meet the acceptance criteria as given in Annexure – 1.
- All the analytical data with calculations to be entered in the work sheet as Annexure-2 all back up date like chromatograms, balance print outs to be enclosed with work sheet only
- QC In charge / His Designee shall review and evaluate the data generated by the analyst. If the results are satisfactory as mentioned above, it can be concluded that the analyst is qualified to perform the particular technique. In case of any discrepancy or abnormality observed, it can be investigated, counseled and by omitting the mistakes, if any training shall be repeated and again evaluated.
- Lectures on technical subjects shall be conducted by qualified in-house / external staff.
- Evaluation of training shall be done by conducting oral / written tests, demonstrations and presentations.
- Apart from the technical training related to Quality Control operation, all additional training is outlined in the SOP “TRAINING OF PERSONAL” SOP No. XYZ by QA department.
4. ABBREVIATIONS
4.1 QC – Quality Control
4.2 QA – Quality Assurance
4.3 SOP – Standard Operating Procedure
4.4 STP – Standard Testing Procedure
5. REFERENCES
- “TRAINING OF PERSONAL IN THE FACTORY”
6. ANNEXURES
6.1 Annexure – 1 Acceptance criteria for qualification of the analyst.
6.2 Annexure – 2 Work sheet
ANNEXURE-1
ACCEPTANCE CRITERIA FOR QUALIFICATION OF ANALYST
| S. No. | Analytical Technique | General Procedure for Training | Acceptance criteria |
| 1. | Assay by HPLC | The analyst shall perform the assay five times (five replicate sample preparation). | 1.The System suitability requirements, if any shall pass. 2.The RSD of five replicate assay values shall be NMT 1%. |
| 2. | Dissolution by UV | The analyst shall perform the dissolution of 6 tablets/capsules approved by following the STP and GTP. | 1.The System suitability requirements, if any shall pass. The RSD for 6 tablets dissolution shall be NMT 5% |
| 3. | Residual Solvents/OVI by GC | The analyst shall perform the test in duplicate (two replicate sample preparations). | 1.The System suitability requirements, if any shall pass. 2.The duplicate values shall be within ± 20% from the average values. |
| 4. | Assay by titrimetry/ Potentiometry | The analyst shall perform the assay five times (five replicate sample preparations). | 1.The RSD of five replicate assay values shall be NMT 1%. |
| 5. | LOD/Water by KF | The analyst shall perform the test five times (five replicate sample preparations). | 1.The RSD of five replicate LOD values shall be NMT 10%. The individual values of water by KF shall be within ± 0.2% from the average value. |
| 6. | TLC (for related substances limit tests/identification) | The analyst shall perform the test in duplicate (two replicate sample preparations). | The System suitability requirements, if any shall pass. The intensity of spots and corresponding Rf values shall match in duplicate samples. |
| 7. | Identification by IR | The analyst shall perform the test in duplicate (two replicate sample preparations). | The spectrum of duplicate sample shall show similar pattern as that of the standard. |
| S. No. | Analytical Technique | General Procedure for Training | Acceptance criteria |
| 8. | a) Sulphated ash b)Residue on ignition c)Loss on ignition d) Heavy metals e) Limit test for Arsenic, Iron, lead. | The analyst shall perform the test in duplicate | Duplicate values shall be within ±0.05% The duplicate solution shall match visually and shall be less than the standard solution. |
| 9. | Bulk density | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match. |
| 10. | Distilling range/melting point/melting range | The analyst shall perform the test in duplicate. | The duplicate values shall match. |
| 11. | Powder fineness . particle size analyzer/by Sieve analysis | The analyst shall perform the test in duplicate | The duplicate values shall match. |
| 12. | Standardization of volumetric solution | Analyst shall standardize any volumetric solution in duplicate. | The difference between the duplicate values shall be not more than 0.2%. |
| 13. | Viscosity | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match. |
| 14. | Specific rotation | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match. |
| 15. | Friability | The analyst shall perform the test in duplicate. | The duplicate values shall match. |
| 16. | Disintegration | The analyst shall perform the test in duplicate | The duplicate values shall match. |
| 17. | Acidity and alkalinity Appearance of solution | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match. |
| 18. | Microbial limit test | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match and should not show different type of colonies. |
| 19. | Chlorides Sulphates | The analyst shall perform the test in duplicate (two replicate sample preparations). | The duplicate values shall match |
| 20. | TOC | The analyst shall perform the cleaning samples in duplicate. | The duplicate value shall match. |
| S. No. | Analytical Technique | General Procedure for Training | Acceptance criteria |
| 21. | Bursting strength tester | The analyst shall perform the test in duplicate | The duplicate value shall match. |
| 22. | Thickness testing (by micrometer) | The analyst shall perform the test in duplicate | The duplicate value shall match. |
| 23. | Dimensions (by scale) | The analyst shall perform the test in duplicate | The duplicate value shall match. |
| 24. | GSM (grammage) | The analyst shall perform the test in duplicate | The duplicate value shall match. |
| 25. | GSM of VMCH coating | The analyst shall perform the test in duplicate | The duplicate value shall match. |
ANNEXURE – 2
Worksheet
| PRODUCT/ MATERIAL: | BATCH No.: | ISSUED ON: |
| SPECIFICATION No.: | A.R.No.: | COPY No.: |
| STP No.: | ISSUED BY: | PAGE No.: |
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