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Quality Control

Quality Control

                                     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

         chromatogram

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


Quality Control General SOPs


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



Quality Control BOOKS




5 comments:

  1. Wonderful Information and great job sir , but why some documents not available

    ReplyDelete
    Replies
    1. updating, soon it will updated

      Delete
  2. I found decent information in your article. I am impressed with how nicely you described this subject, It is a gainful article for us. Thanks for share it. mms2 capsules jim humble

    ReplyDelete
  3. cant thank you enough for what you've shared

    ReplyDelete
  4. hi nice information , but why Indian pharmacopeia not available

    ReplyDelete