Analyst Qualification Criteria

Pharmaceutical Industry Analyst Qualification Criteria | Analyst Qualification for Quality Control Laboratory |

GroupSr. No.Analytical TechniqueQualification ProcedureAcceptance Criteria
A PHYSICAL PARAMETERS (Non-complex Analytical Techniques)
 1Description / CharacteristicsTo be performed on routine sample with Qualified Analyst (single analysis)Individual results must comply with the specifications
 2Solubility
 3Appearance of Solution / Colour and Clarity of Solution
 4Heavy Metals
 5Limit tests such as Chloride, Sulphate, Nitrate, Lead, Iron, Arsenic etc.
 6Hardness
 7Thickness
 8Dimension
 9Preparation and Standardization of Volumetric solutions.
 10GSM analysis of Packing Material  
B CHEMICAL PARAMETERS (Complex Analytical Techniques)
 1pH of SolutionTo be performed on routine raw material / finished product sample with Qualified Analyst in duplicate.Individual results must comply with the specifications.
 2Sulphated Ash/ Residue on Ignition
 3Loss on Ignition
 4Loss on Drying
 5Bulk Density (Tapped / Untapped)
 6Distillation range
 7Melting Point
 8Friability
 9Disintegration test
 10Thin Layer Chromatography
B CHEMICAL PARAMETERS    (Complex Analytical Techniques)
 11Determination of conductivityTo be performed on routine raw material / finished product sample with Qualified Analyst in duplicate.Individual results must comply with the specifications.
 12Refractive index
 13Specific Optical Rotation
 14Particle Size (by sieve analysis)
 15Total Organic Carbon
 16Viscosity
 17Water by Karl Fisher
C TITRATION    (Complex Analytical Techniques)
 1Assay by Potentiometry  To be performed on routine raw material / finished product sample with Qualified Analyst in duplicatea. 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.
 2Assay by Manual titration
D INSTRUMENTAL   (Complex Analytical Techniques)
 1Identification
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.
 2Dissolution
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)
 3Assay 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.
 4Purity
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)
 5Related substances or chromatographic purity
1. By HPLC
To be performed on routine raw material / finished product sample with Qualified Analyst in duplicatea. 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
 6Residual 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)
 1Inoculum Preparation and Growth Promotion TestTo be performed the routine activities with Qualified AnalystAs per requirement
 2Culture Transfer
 3Media Preparation
 4Environment Monitoring
 MICROBIOLOGICAL  (Complex Analytical Techniques)
 1Sterility TestTo be performed on routine sterile sample or sterile water sample in presence of Qualified Microbiologist.Individual result must comply with the specification.
 2Bacterial Endotoxins TestTo be performed on routine raw material / finished product sample in presence of Qualified MicrobiologistIndividual result must comply with specification.
 3Microbiological AssayTo 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  TestTo 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.ChecklistObservation (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