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WHO SOP List for Pharma Microbiology


List of Standard operating procedures for microbiology should be available as per WHO.

WHO SOPs for Pharma Microbiology:



Sr. No.
Name of SOP
1.
SOP Of General Guidelines For Microbiology Laboratory.
2.
SOP of Entry In Microbiology Section.
3.
SOP Of Cleaning In Microbiology Section.
4.
SOP of media preparation.
5.
SOP Of Growth Promotion Test Of Culture Media.
6.
SOP of  Determination of Bacteriological Quality of Water.
7.
SOP of Gram Staining And Motility.
8.
SOP of Destruction Of Cultures & Microbiological Media.
9.
SOP of Environmental Monitoring.
10.
SOP of Sub culturing of the Microbial cultures.
11.
SOP of Culture Titer Preparation.
12.
SOP of Fumigation Process By Fogger Method In Micro.
13.
SOP of Microscope.
14.
SOP of MLT of In process, Finished Product And Raw Material.
15.
SOP of MLT of Packing material.
16.
SOP of Operation & Cleaning Of Pass Box.
17.
SOP of Operation of BOD Incubator.
18.
SOP of Operation of Incubator.
19.
SOP of Operation, Maintenance and calibration of Heating Block.
20.
SOP of Recording of Differential Pressure.
21.
Procedure for Qualification of Biological Indicator.
22.
SOP of bacterial Endotoxin Test.
23.
SOP of Sterility Test.
24.
SOP of Sterility of Compressed Air, Nitrogen & Carbon dioxide.
25.
SOP of sterility failure investigation.
26.
SOP of Sterilization by Autoclaving.
27.
SOP of Monitoring of UV Light Efficiency of LAF & Pass Box.
28.
SOP of Operation, Maintenance and calibration of Hot Air Oven.
29.
SOP of Operating Instruction of LAF.
30.
SOP of Operation, Maintenance & Calibration of Colony counter.
31.
SOP of Operation of Air Sampler.
32.
SOP of Glassware’s cleaning.
33.
Sop of Entry and Exit in Microbiological testing area.
34.
SOP of Calibration of micro pipettes.
35.
SOP of Pathogen Testing of Drains.
36
SOP of Depyrogenation of glass ware.
37
SOP for Personnel Monitoring in Aseptic Area.
38
SOP for Pure Steam Generation.
39
SOP for Preparation of disinfectant solution.
40
SOP for Garment Washing.
41
Procedure For Determination Of Surface Quality Of equipments.
42
SOP for Operation of horizontal autoclave.
43
SOP for Operation of vertical autoclave.
44
SOP for MLT Of Compressed Air.
45
SOP for Handling of Lysate.
46
Handling of Sampling tools.
47
SOP for Operation of Discard autoclave.
48
Disposal of contaminated Material.
49
Disinfectant Efficacy Test
50
Personnel qualification of personnel Entering in to aseptic area and in sterility testing area.
51
Destruction of media fill vials



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