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List of Standard Operating Procedures (SOPs) in Quality Control (QC)


View the list of Standard operating procedures for Pharmaceutical instrument calibration and operation.

Click here to view these SOPs
01. -Entry and Exit procedure in QC Lab
02. -Testing and retesting of raw material
03. -Operation and calibration of Analytical balance
04. -Preparation and standardization of Volumetric Solution
05. -Operation of  HPLC system using chemestore  software
06. -Calibration of HPLC system  using chemestore  software
07. -Operation and Calibration of water bath
08. -Operation and Calibration of Refractometer
09. -Operation of UV- Visible Spectrophotometer
10. -Operation of  Sieve shaker
11. -Operation and Calibration of Melting Point apparatus
12. -Operation of UV cabinet
13. -Analysis of In process samples
14. -Operation and calibration of leak test apparatus
15. -Operation of Milli- Q water system
16. -Analytical Method validation by HPLC
17. -Operation and Calibration of Conductivity/TDS meter
18. -Operation and calibration of pH meter pico+
19. -Operation and calibration of tap density apparatus
20. -Cleaning of Glassware used in Chemical & Inst. - analysis
21. -Cleaning of Sampling Equipment
22. -Storage and use of reagent chemicals
23. -Handling of glassware
24. -Operation and calibration of Hot Air Oven
25. -Cleaning of Refrigerator
26. -Operation of Muffle Furnace
27. -Cleaning of  QC laboratory
28. -Handling of sample of In- process and finished product
29. -Maintenance of Desiccators
30. -Preparation of standard, general  indicator solution
31. -Operation of Vernier caliper
32. -Storage conditions of raw & packaging material
33. -HPLC Analysis and  Documentation 
34. -Monitoring of raw and potable water quality
35. -Monitoring of water for injection
36. -Operation and Calibration of FT-IR spectrometer
37. -Calibration of gas chromatography
38. -Post production stability study
39. -Monitoring of purified quality
40. -Sampling of raw material
41. -Preventive maintenance of instrument
42. -Storage of sampling tool
43. -Calibration of glass ware
44. -Procedure for glass ware washing
45. -Sampling and analysis of rinse water
46. -Operation and calibration of polarimeter
47. -Calibration of UV Spectrometer
48. -Handling of general non compliance incident
49. -Approval and rejection of packing material
50. -Inspection and sampling of packing material
51. -Identification of microorganism
52. -Media preparation and growth promotion test
53. -Operation and calibration  of  Metrohm  titrometer
54. -Control environment chamber at 40 ºC and RH 75 %
55. -Control environment chamber at 25ºC and RH 60 %
56. -Operation and calibration of microscope
57. -Record of analysis sheet
58. -Sterility test
59. -Culture maintenance
60. -Operation of Horizontal Autoclave
61. -Entry, exit and gowning procedure in micro lab 
62. -Maintenance and sub culturing of microbial culture
63. -Operating procedure of air sampler
64. -Operation of dry heat sterilizer
65. -Operation of vertical autoclave
66. -Operation and sterility monitoring of LAF
67. -Validation autoclave with biological indicator for sterilization efficiency
68. -Calibration of colony counter
69. -Calibration of hot air oven
70. -Calibration procedure of BOD and bacteriological incubator
71. -Operation of Bacteriological incubator
72. -Endotoxin test procedure
73. -Preparation of culture of microorganism
74. -The enumeration of spore counting biological indicator
75. -Procedure for opening of lyophilized vial of microorganism
76. -Laminar flow work bench
77. -Preservative efficacy test
78. -Cleaning of micro lab
79. -Analysis and release of finished product
80. -Good Laboratory Practice
81. -Cleaning of micro glass ware
82. -Recording of analytical data in raw data sheet
83. -Safety measure in QC
84. -Analytical reference number
85. -Backup restore of analytical chromatogram
86. -Record of analysis sheet
87. -Procedure of  Swab sampling
88. -Environment monitoring program
89. -Environment monitoring by air sampling and settling  plate
90. -Media inventory control
91. -Operation of Incubator-1
92. -Operation of Incubator-2
93. -Bio safety cabinet
94. -Quantification of culture
95. -Analyst Validation
96. -Handling of reference and working standard
97. -Operation of particle counter
98. -Operation and monitoring of dynamic pass box
99. -Operation and monitoring of garment cabinet
100. -Operation and calibration of sonicator
101. -Operation and of centrifuge
102. -Operation and calibration of Bursting strength tester
103. -Operation of Magnetic stirrer
104. -Operation of Micrometer
105. -Operation and calibration of Vacuum, oven
106. -Operation and calibration of pH  meter pH tutor
107. -Operation and calibration of pH  meter GMPH
108. -Microbial limit test
109. -Testing of miscellaneous sample
110. -Microbial monitoring of compressed air and Nitrogen gas
111. -Training Procedure of QC persons
112. -Cleaning Policy
113. -Surface Area
114. -Swab for cleaning validation
115. -Worst Case
116. -Hole time study of clean and dirty equipment
117. -Operation and calibration of dry bath
118. -Media Destruction 
119. -Calibration of Thermometer
120. -Fumigation in Micro Lab
121. -Preparation and Bioburdon of 70 % IPA
122. -Testing of Process validation Sample
123. -Validation of Microbiologist
124. -Operation and Calibration of TOC
Click here to view these SOPs




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