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

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 glassware
44. Procedure for glassware 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 subculturing 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 workbench
77. Preservative efficacy test
78. Cleaning of micro lab
79. Analysis and release of finished product
80. Good Laboratory Practice
81. Cleaning of micro glassware
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. Biosafety 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