Quality Control Testing SOP
1. Determination of humidity and relative humidity by using hygrometer
2. Counting of
airborne particle by using particle counter
3. Absorbance ortransmittance reading on UVVIS Spectrophotometer
4. Determination of% L.O.D by moisture analyzer
5. Determination of% L.O.D by using desiccator
6. Determination of
% L.O.D by using hot air oven
7. Determination of
colonies on a culture plate by using colony counter
8. Determination of differential pressure by using pressure gauge
9. Determination of
Melting point of given sample by using melting point apparatus
10. Determination of moisture content by coulometric karl fischer
11. Determination of moisture content by volumeteric karl fischer
12. Determination of refractive index by using refractometer
13. Determination of
specific gravity by pycnometer
14. Determination of viscosity
15. High Performance Liquid Chromatography (HPLC) and calculation of
16. Testing specificoptical rotation of a sample
17. Blister sealing
leak test for strips
18. Conductivitymeasurement of a solution by using conductometer
19. Disintegrationtest for capsules
20. Disintegrationtest for delayed release cap
21. Disintegrationtest for enteric coated tablets
22. Disintegration
test for tablets
23. DT for
conventional and prolonged-release SDF
24. DT for
delayed-release SDF
25. Friability test
26. hardness test of
tablets
27. Leak test for
bottles
28. particle size
determination of granules
29. pH testing
30. Potentiometric
titration
31. swelling index
32. tapped density
test of granules
33. thickness,
diameter & hardness test of tablets
34. thickness,
diameter test of tablets
35. Uniformity of
content of single dose prep.
36. Uniformity of
dosage units by content uniformity for liquid or semi-liquid DF
37. Uniformity of
dosage units by content uniformity for sdf
38. Uniformity of
dosage units by mass variation for granules)powders
39. Uniformity of
dosage units by mass variation for hard capsules
40. Uniformity of
dosage units by mass variation for lquids or semi-liq DF
41. Uniformity of
dosage units by mass variation for tab
42. Uniformity of wt.
test for capsules, granules and powders
43. Uniformity of wt.
test for tablets
44. Weight per ml
test for liquids
1. Role Of Quality Control Department In Rejection
2. Retention Of Old Record Of Quality Control
3. Testing,
Release & Rejection Of Raw Materials
4. Retesting Schedule Of Raw Material
5. Preparation And Standardization Of Volumetric Solution
6. Storage
And Use Of Reagents & Chemicals
7. Release Of Finished Product
8. Training Procedure For Quality Control Personnel
9. Safety In Quality Control
10. Q.C Laboratory Safety
11. Handling
& Usage Of Hazardous Chemiclas
12. Q.C Laboratory Safety
13. Preventive Maintenance Of All Qc Instrument
14. Preparation And Handling Of Working Standrds
15. Procurement And Handling Of Reference Standards
16. Preservation Of Control Samples Of Active Ingredients
17. Preparation And Handling Of Primary Standard
18. Q.C Laboratory Cleaning
19. Preparation Of Cleansing Agents For Glassware Washing
20. Handling Of The Spillages In The Q.C Laboratory
21. Handling Of Reference And Working Standards
22. Handling And Testing Of Various Samples
23. Handling Of Glassware
24. Handling And Testing Of Various Samples
25. Handling And Testing Of In-Process Sample
26. Out Of Specification (Oos)
27. Function Of Quality Control Department
28. Handling And Control For Prohibited Items
29. General Test Procedure.
30. Collection
And Storage Of Retained Samples Of Packaging Material
31. Careful Handling Of Poisonous Chemicals
32. Behavior In Quality Control Department
33. Action To Be Taken For Unusual Observation For Instrument During
Calibration
34. Collection And Storage Of Retained Samples Of Raw Material
35. Cleaning Of Quality Control Department Throughout Working
36. Storage Of Sampling Tools
37. Cleaning Of Sampling Equipments
38. Sampling Of Raw Material In Pharmaceuticals
39. Standard,General Reagents, Indicator Solutions
40. Preventive Maintenance Of Instrument
41. Analysis And Release Of Finished Product Sample
42. Record Maintained By Quality Control
43. Testing
& Release Of In-Process Samples
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