Pharmaceutical Industry Analyst Qualification Criteria | Analyst Qualification for Quality Control Laboratory |
| Group | Sr. No. | Analytical Technique | Qualification Procedure | Acceptance Criteria |
| A | PHYSICAL PARAMETERS (Non-complex Analytical Techniques) | |||
| 1 | Description / Characteristics | To be performed on routine sample with Qualified Analyst (single analysis) | Individual results must comply with the specifications | |
| 2 | Solubility | |||
| 3 | Appearance of Solution / Colour and Clarity of Solution | |||
| 4 | Heavy Metals | |||
| 5 | Limit tests such as Chloride, Sulphate, Nitrate, Lead, Iron, Arsenic etc. | |||
| 6 | Hardness | |||
| 7 | Thickness | |||
| 8 | Dimension | |||
| 9 | Preparation and Standardization of Volumetric solutions. | |||
| 10 | GSM analysis of Packing Material | |||
| B | CHEMICAL PARAMETERS (Complex Analytical Techniques) | |||
| 1 | pH of Solution | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | Individual results must comply with the specifications. | |
| 2 | Sulphated Ash/ Residue on Ignition | |||
| 3 | Loss on Ignition | |||
| 4 | Loss on Drying | |||
| 5 | Bulk Density (Tapped / Untapped) | |||
| 6 | Distillation range | |||
| 7 | Melting Point | |||
| 8 | Friability | |||
| 9 | Disintegration test | |||
| 10 | Thin Layer Chromatography | |||
| B | CHEMICAL PARAMETERS (Complex Analytical Techniques) | |||
| 11 | Determination of conductivity | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | Individual results must comply with the specifications. | |
| 12 | Refractive index | |||
| 13 | Specific Optical Rotation | |||
| 14 | Particle Size (by sieve analysis) | |||
| 15 | Total Organic Carbon | |||
| 16 | Viscosity | |||
| 17 | Water by Karl Fisher | |||
| C | TITRATION (Complex Analytical Techniques) | |||
| 1 | Assay by Potentiometry | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate | a. Individual results must comply with specification. b. Individual values must be within ±1.0% of the average value. c. Average value must be within ±1.0% of the result of Qualified Analyst. | |
| 2 | Assay by Manual titration | |||
| D | INSTRUMENTAL (Complex Analytical Techniques) | |||
| 1 | Identification 1. By FTIR 2. By UV Spectrophotometry | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | Individual results must comply with specification. | |
| 2 | Dissolution 1. By HPLC 2. By UV Spectrophotometry | To be performed on six units of routine raw material / finished product sample with Qualified Analyst in duplicate. | a. Individual results must comply with specification. b. The minimum and the maximum values obtained must be within ±5% of the result of Qualified Analyst. c. Difference between duplicate average value must be within ± 5%. | |
| D | INSTRUMENTAL (Complex Analytical Techniques) | |||
| 3 | Assay By 1. HPLC 2. By UV Spectrophotometry | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | a. Individual results must comply with specification. b. The average assay result obtained must be within ±1% of the result of Qualified Analyst for API. c. Individual value must be within ± 1% of the average value for raw material. d. The average assay result obtained must be within ±2% of the result of Qualified Analyst for Finished product. e. Individual value must be within ± 2% of the average value for finished product. | |
| 4 | Purity 1. By HPLC 2. By GC | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | a. Individual results must comply with specification. b. Original result / Allowed variation from the result of Qualified Analyst i. Less than or equal to 90.0% / ± 5% ii. Between 90.1% and 98.0% / ± 2% iii. Between 98.1% and 100.0% / ± 1% c. Individual value must be within ± 1% of the average value for raw material. d. Individual value must be within ± 2% of the average value for finished product. | |
| D | INSTRUMENTAL (Complex Analytical Techniques) | |||
| 5 | Related substances or chromatographic purity 1. By HPLC | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate | a. Individual results must comply with specification. b. Original result / Allowed variation from the result of Qualified Analyst i. Less than 0.05% / No criteria ii. Between 0.05% and 0.10% / ± 0.02 iii. Between 0.11 % and 0.50% / ± 0.05 iv. Between 0.51 % and 1.0% / ± 0.10 v. More than 1.0% / ± 0.20 | |
| 6 | Residual Solvents by 1. Gas Chromatography | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | a. If the result is less than 100 ppm must comply with specification. b. If the result is more than 100 ppm, i. Individual results must comply with specification. ii. Average value must be within ±15% of the result of Qualified analyst. | |
| E | MICROBIOLOGICAL (Non-complex Analytical Techniques) | |||
| 1 | Inoculum Preparation and Growth Promotion Test | To be performed the routine activities with Qualified Analyst | As per requirement | |
| 2 | Culture Transfer | |||
| 3 | Media Preparation | |||
| 4 | Environment Monitoring | |||
| MICROBIOLOGICAL (Complex Analytical Techniques) | ||||
| 1 | Sterility Test | To be performed on routine sterile sample or sterile water sample in presence of Qualified Microbiologist. | Individual result must comply with the specification. | |
| 2 | Bacterial Endotoxins Test | To be performed on routine raw material / finished product sample in presence of Qualified Microbiologist | Individual result must comply with specification. | |
| 3 | Microbiological Assay | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | a. Individual results must comply with the specifications. b. Individual values must be within ±5.0% of the average value. c. Average value must be within ±5.0% of the result of Qualified Analyst. | |
| 4 | Microbial Enumeration Test | To be performed on routine raw material / finished product sample with Qualified Analyst in duplicate. | a. Individual results must comply with the specifications. b. Result obtained must not vary by more than 25% of the result of Qualified Analyst | |
Checklist for Analyst Qualification
| Name of the Analyst: | |||
| Employee ID: | A.Q. No.: | ||
| Product / Material: | Batch / Lot Number: | ||
| Test being performed: | |||
| Name of the Trainer: | Date: | ||
| Sr. No. | Checklist | Observation (Yes / No / NA) |
| 1. | Is the analyst using the correct analytical method for performing the analysis? | |
| 2. | Is the analyst referring to relevant Standard Operating Procedure / Testing Procedure while performing the analysis? | |
| 3. | Is the analyst using calibrated equipment / instrument for performing the analysis? | |
| 4. | Is the analyst using the working standard / reference standard, if any within their validity period? | |
| 5. | Is there evidence that the chemicals / solutions/ reagents used during the analysis were within their validity period? | |
| 6. | Is it evident that the analyst is taking all the safety precautions? | |
| 7. | Is the analyst using the analytical balance correctly? | |
| 8. | Is the analyst using clean weighing accessories, like spatula, butter paper, etc.? | |
| 9. | Is the solution prepared by the analyst labeled appropriately? | |
| 10. | Is the analyst following the correct pipetting technique, if any? | |
| 11. | Is the analyst using the correct glassware / reagents / chemicals / as mentioned in the analytical method? | |
| 12. | Are samples/ solutions stored appropriately during the analysis? |
| Specific Observations for the Analytical Technique | |
| Trainer (Sign): | Date: |
For SOP of Analyst Qualification click link: Analyst Qualification SOP