10.August.

2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
STANDARD OPERATING PROCEDURES INSTRUMENTS
EQUIPMENT
S.NO NAME SOP CODE AUTHOR
CODE
1. HIGH PERFORMANCE LIQUID SN/QC/EQP/01 SN/QC/SOPI/001 QCM
CHROMATOGRAPHY
2. SPECTROPHOTOMETER SN/QC/EQP/02 SN/QC/SOPI/002 QCM
3. KARL FISCHER TITRATOR SN/QC/EQP/03 SN/QC/SOPI/003 QCM
4. DISSOLUTION TEST APPARATUS SN/QC/EQP/04 SN/QC/SOPI/004 QCM
5. DISINTEGERATION TEST SN/QC/EQP/05 SN/QC/SOPI/005 QCM
APPARATUS
6. FRIABILITY TESST APPARATUS SN/QC/EQP/06 SN/QC/SOPI/006 QCM
7. MELTING POINT APPPARATUS SN/QC/EQP/07 SN/QC/SOPI/007 QCM
8. BALANCE SN/QC/EQP/08 SN/QC/SOPI/008 QCM
9. PH METER SN/QC/EQP/09 SN/QC/SOPI/009 QCM
10. OVEN SN/QC/EQP/10 SN/QC/SOPI/010 QCM
11. HOT AIR INCUBATOR SN/QC/EQP/11 SN/QC/SOPI/011 QCM
12. COOL INCUBATOR SN/QC/EQP/12 SN/QC/SOPI/012 QCM
13. AIR SAMPLER SN/QC/EQP/13 SN/QC/SOPI/013 QCM
14. DIGITAL HARDNESS TESTER SN/QC/EQP/14 SN/QC/SOPI/014 QCM
15. VACCUME PUMP SN/QC/EQP/15 SN/QC/SOPI/015 QCM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
16. WATER BATH SN/QC/EQP/16 SN/QC/SOPI/016 QCM
17. MICROSCOPE SN/QC/EQP/17 SN/QC/SOPI/017 QCM
18. MAGNETIC STIRRER HOT (PLATE) SN/QC/EQP/18 SN/QC/SOPI/018 QCM
19. COLONY COUNTER SN/QC/EQP/19 SN/QC/SOPI/019 QCM
20. LAMINAR FLOW CABINET SN/QC/EQP/20 SN/QC/SOPI/020 QCM
21. AUTOCLAVE SN/QC/EQP/21 SN/QC/SOPI/021 QCM
22. CONDUCTIVITY METER SN/QC/EQP/22 SN/QC/SOPI/022 QCM
23. STERILITY TEST ASSEMBLY SN/QC/EQP/23 SN/QC/SOPI/023 QCM
24. PARTICL COUNTER SN/QC/EQP/24 SN/QC/SOPI/024 QCM
25. LUX METER SN/QC/EQP/25 SN/QC/SOPI/025 QCM
26. MAGNIFYING GLASS SN/QC/EQP/26 SN/QC/SOPI/026 QCM
27. MOISTURE ANALYZER SN/QC/EQP/27 SN/QC/SOPI/027 QCM
28. SONICATOR SN/QC/EQP/28 SN/QC/SOPI/028 QCM
29. STABILITY CHAMBER SN/QC/EQP/29 SN/QC/SOPI/029 QCM
30. FLASK SHAKER SN/QC/EQP/030 SN/QC/SOPI/030 QCM
31. VERNIER CALIPER SN/QC/EQP/31 SN/QC/SOPI/031 QCM
32. SCREW GAUGE SN/QC/EQP/032 SN/QC/SOPI/032 QCM
33. TAPPED DENSITY APPARATUS SN/QC/EQP/33 SN/QC/SOPI/033 QCM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
34. POLARIMETER SN/QC/EQP/34 SN/QC/SOPI/034 QCM
35. LEAK TEST APPARATUS SN/QC/EQP/35 SN/QC/SOPI/035 QCM

GENERAL SOP (File # 14)

S.NO NAME SOP CODE AUTHOR

36. Procedure For Document, Data & QCM
Record Control SN/QSP/MR/001
37. Procedure For Corrective & Preventive SN/QSP/MR /003 QCM
Action
38. Procedure For Management Review SN/QSP/MR /002 QCM
Meeting
39. Procedure For Training. SN/QSP/MR /007 QCM

40. Procedure For Objective & Targets SN/QSP/MR /005 QCM

41. Procedure Internal Audit SN/QSP/MR /004 QCM

42. Procedure For Internal Communication SN/QSP/MR /006 QCM

43. Procedure For External Communication SN/QSP/MR /008 QCM

44. Procedure For Change Control SN/QSP/MR /009 QCM

Management
45. Procedure for working in Quality SN/QC/SOP/001 QCM
Control Lab

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
46. Procedure for cleaning in Quality SN/QC/SOP/002 QCM
Control Lab
47. Procedure for entry and exit into SN/QC/SOP/003 QCM
Quality Control Lab
48. SOP for cleaning of Glass wares SN/QC/SOP/004 QCM

49. Procedure for washing and handling of SN/QC/SOP/005 QCM

HPLC column
50. Procedure for storage and handling of SN/QC/SOP/006 QCM
Working Reference standard
51. Responsibilities of quality control SN/QC/SOP/007 QCM
department
52. Procedure for Stability Testing SN/QC/SOP/008 QCM

53. Procedure for Preparation and SN/QC/SOP/009 QCM

standardization of reagents
54. Product recalls SN/QC/SOP/010 QCM

55. Reference standard SN/QC/SOP/011 QCM

56. Return goods SN/QC/SOP/012 QCM

57. Out of specification material SN/QC/SOP/013 QCM

58. Customer compliant handling SN/QC/SOP/014 QCM

59. Destruction of products SN/QC/SOP/015 QCM

60. In process testing SN/QC/SOP/016 QCM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
61. Sampling and testing of packing SN/QC/SOP/017 QCM
material
62. Procedure for thermal mopping SN/QC/SOP/018 QCM

63. Raw material sampling and testing SN/QC/SOP/019 QCM

64. Procedure for R.O water SN/QC/SOP/020 QCM

65. Media fill trials SN/QC/SOP/021 QCM

66. Tamper evident of packing SN/QC/SOP/022 QCM

67. Procedure for hold time study SN/QC/SOP/023 QCM

68. Procedure for content uniformity SN/QC/SOP/024 QCM

69. Procedure for monitoring of noise and SN/QC/SOP/025 QCM

light intensity
70. SOP for Disposal of Expired SN/QC/SOP/026 QCM
Chemicals, Reagents, Solvents and
Microbiological Medium
71. SOP for Calibration of Micropipette SN/QC/SOP/027 QCM

72. SOP for Product failure, Laboratory SN/QC/SOP/028 QCM

Failure, Stability Failure
73. SOP for failure investigation SN/QC/SOP/029 QCM

74. SOP for Annual product review SN/QC/SOP/030 QCM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
75. SOP for SOP’s SN/QC/SOP/031 QCM

76. SOP for Safety & Security at QC SN/QC/SOP/032 QCM

Department
77. SOP for development/Revision of SN/QC/SOP/033 QCM
artwork
78. SOP for Supplier evaluation SN/QC/SOP/034 QCM

79. SOP for handling and cleaning of QC SN/QC/SOP/035 QCM

equipments
80. Procedure for swab sampling of SN/QC/SOP/036 QCM
equipment/machine for physical &
chemical testing
81. SOP for passivation of equipments and SN/QC/SOP/037 QCM
machine parts
82. SOP for assigning QC number and SN/QC/SOP/038 QCM
equipment code.
83. SOP of chemical spill procedure SN/QC/SOP/039 QCM

84. SOP for proper use of a chemical fume SN/QC/SOP/040 QCM

hood
85. SOP for Hazardous And Toxic SN/QC/SOP/041 QCM
Chemicals/Reagents Management
86. SOP For Cleaning And Sanitization Of SN/QC/SOP/042 QCM
Pharmaceutical Facility
87. SOP For Risk Management SN/QC/SOP/043 QCM

88. SOP For Trend Analysis SN/QC/SOP/044 QCM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
89. SOP For Self Inspection Follow Up SN/QC/SOP/045 QCM

90. SOP For Continuous Improvement SN/QC/SOP/046 QCM

91. SOP For Analyst Qualification In SN/QC/SOP/047 QCM

Quality Control
92. SOP For Control Sample Management SN/QC/SOP/048 QCM

93. SOP for Cleaning Validation SN/QC/SOP/VAL/001 QCM

94. Procedure for maintenance and SN/QC/SOP/CAL/001 QCM

calibration of equipments
95. Method validation SN/QC/SOP/CAL/002 QCM

96. Procedure for Calibration of SN/QC/SOP/CAL/003 QCM

Polarimeter
97. Calibration of glass ware SN/QC/SOP/CAL/004 QCM

98. Calibration of pH meter SN/QC/SOP/CAL/005 QCM

99. SOP for calibration of Analytical SN/QC/SOP/CAL/006 QCM

Balance
100. SOP for calibration of SN/QC/SOP/CAL/007 QCM
Spectrophotometer
101. SOP for calibration of Dissolution SN/QC/SOP/CAL/008 QCM
Apparatus
102. SOP for calibration of Disintegration SN/QC/SOP/CAL/009 QCM
Apparatus
103. SOP for calibration of Moisture SN/QC/SOP/CAL/010 QCM
Analyzer
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST

PRODUCT SAP’S (File # 05 & 52)

SR.# SOP #
DRN PRODUCT NAME
AUTHOR
104. FITCID 30MG CAPSULES SN/QC/SAPP/001 QCM
Each capsule Contains:-
049369 Lansoprazole as enteric coated
Pellets……………....30mg.
(USP Specs)
105. CEXIME 400MG CAPSULES. SN/QC/SAPP/002 QCM
Each Capsule Contains:-
049401
Cefixime as Trihydrate………..400mg.
(USP Specs)
106. LYMFO CAPSULES. SN/QC/SAPP/003 QCM
Each Capsule Contains:-
Iron III Hydroxide Polymaltose
049399 Complex
Eq. to. Elemental Iron………….100mg.
Folic Acid……………….0.35mg.
(Shawan’s Specs)
107. OMEYZ 20MG CAPSULES SN/QC/SAPP/004 QCM
Each capsule Contains:-
049370 Omeprazole as enteric coated
Pellets…………………....20mg.
(USP Specs)
108. 049398 SEPRETINE CAPSULES. SN/QC/SAPP/005 QCM
Each Capsule Contains:-
Fluoxetine as Hcl...……………..20mg.
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
(USP Specs)
109. SHAEZ 40MG CAPSULES SN/QC/SAPP/006 QCM
Each capsule Contains:-
049371 Esomeprazole Magnesium Trihydrate
Pellets eq. to Esomeprazole….40mg.
(USP Specs)
110. SHAEZ 20MG CAPSULES SN/QC/SAPP/007 QCM
Each capsule Contains:-
049372 Esomeprazole Magnesium Trihydrate
Pellets eq. to Esomeprazole….20mg.
(USP Specs)
111. SHAWBAL CAPSULES SN/QC/SAPP/008 QCM
Each Capsule Contains:-
052671
Mecobalamin…………..500mcg.
(Shawan’s Specs)
112. SHIME CAPSULES. SN/QC/SAPP/009 QCM
Each Capsule Contains:-
049400 Cefpodoxime as Proxetil…………
100mg.
(USP Specs)
113. TEROX 250MG CAPSULES. SN/QC/SAPP/010 QCM
Each Capsule Contains:
063465 Ciprofloxacin as (HCL) ……….250mg
(USP Specs.)

114. TEROX 500MG CAPSULES. SN/QC/SAPP/011 QCM

Each Capsule Contains:
063466
Ciprofloxacin as (HCL) ……….500mg
(USP Specs.)

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
115. WADIN 250MG CAPSULES. SN/QC/SAPP/012 QCM
Each Capsule Contains:-
049403 Cephradine as Monohydrate….250mg.
(USP Specs)

116. WADIN 500MG CAPSULES. SN/QC/SAPP/013 QCM

Each Capsule Contains:-
049404
Cephradine as Monohydrate….500mg.
(USP Specs)
117. XEGEN 20MG CAPSULES. SN/QC/SAPP/014 QCM
Each Capsule Contains:-
049396
Piroxicam………………………..20mg.
(USP Specs)
118. XEGTIN CAPSULES SN/QC/SAPP/015 QCM
Each capsule Contains:-
052672 Piroxicam (as beta cyclodextrin)
…………....20mg.
(BP Specs)
119. ZITON 250MG CAPSULES. SN/QC/SAPP/016 QCM
Each Capsule Contains:-
049402 Azithromycin…………………...250mg
.
(USP Specs)
120. Recute 20 mg Capsules SN/QC/SAPP/017 QCM
Each Capsule Contains:
069814
Isotretinoin………….20mg
(Shawan’s Specs.)
121. 049397 STICK CAPSULES. SN/QC/SAPP/018 QCM
Each Capsule Contains:-
Cefadroxil as monohydrate..…..500mg.
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Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
(USP Specs)
122. AMIZIP 100MG TABLETS SN/QC/SAPP/019 QCM
Each Tablet Contains:-
056387
Clozapine.........100mg.
(USP Specs).
123. AMIZIP 25MG TABLETS SN/QC/SAPP/020 QCM
Each Tablet Contains:-
056388
Clozapine.........25mg.
(USP Specs.)
124. BANXIN 250MG TABLETS SN/QC/SAPP/021 QCM
Each Tablet Contains:-
049378
Ciprofloxacin as Hcl…250mg.
(USP Specs)
125. BANXIN 500MG TABLETS SN/QC/SAPP/022 QCM
Each Tablet Contains:-
049379
Ciprofloxacin as Hcl…500mg.
(USP Specs)
126. Evotrazin 5MG TABLETS SN/QC/SAPP/023 QCM
Each Tablet Contains:-
060179
Levocetirazine ……..5mg
(Shawan’s Specs.)
127. HARICAM 7.5MG TABLETS SN/QC/SAPP/024 QCM
Each Tablet Contains:-
056389
Meloxicam.........7.5mg.
(B.P Specs).
128. HARICAM 15MG TABLETS. SN/QC/SAPP/025 QCM
Each Tablet Contains:-
056390
Meloxicam.........15mg.
(B.P Specs.

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
129. LOFEN 75MG TABLETS. SN/QC/SAPP/026 QCM
Each Tablet Contains:-
049385
Diclofenac Potassium.........75mg.
(B.P Specs)
130. MONAZ 5MG TABLETS SN/QC/SAPP/027 QCM
Each tablet contains
056391
Montelukast as sodium … 5 mg
Shawan’s specs
131. MONAZ 10MG TABLETS SN/QC/SAPP/028 QCM
Each tablet contains
056392
Montelukast as sodium … 10 mg
Shawan’s specs
132. NEAMIN TABLETS. SN/QC/SAPP/029 QCM
Each Tablet Contains:
063471
Mecobalamine……….500mcg
(Shawan Specs.)
133. OMARID 1 MG TABLETS. SN/QC/SAPP/030 QCM
Each Tablet Contains:
063467
Glimepiride……….1mg
(BP Specs.)
134. OMARID 2 MG TABLETS. SN/QC/SAPP/031 QCM
Each Tablet Contains:
063468
Glimepiride……….2mg
(BP Specs.)
135. OMARID 3 MG TABLETS. SN/QC/SAPP/032 QCM
Each Tablet Contains:
063469
Glimepiride……….3mg
(BP Specs.)
136. 063470 OMARID 4 MG TABLETS. SN/QC/SAPP/033 QCM
Each Tablet Contains:
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
Glimepiride……….4mg
(BP Specs.)
137. P-SESQ TABLETS. SN/QC/SAPP/034 QCM
Each Enteric coated Tablet Contains:-
049377 Pantoprazole as sodium
Sesquihydrate…40mg.
(Shawan’s Specs)
138. PYZED 20 MG TABLETS. SN/QC/SAPP/035 QCM
Each Tablet Contains:
Piroxicam (as beta cyclodextrin)
063463
……….20mg
(Shawan Specs.)

139. SHAFLO TABLETS. SN/QC/SAPP/036 QCM

Each Tablet Contains:-
049383
Ofloxacin.......…………..200mg
(USP Specs)
140. Shamin 10MG TABLETS SN/QC/SAPP/037 QCM
Each Tablet Contains:-
060178
Loratidine……..10mg
(USP Specs.)
141. SHAPRAM 10MG TABLETS SN/QC/SAPP/038 QCM
Each Tablet Contains:-
049380 Escitalopram as Oxalate…10mg.
(Shawan’s Specs)

142. TAZADIN 2 MG TABLETS. SN/QC/SAPP/039 QCM

Each Tablet Contains:
063459
Tizanidine as HCL……….2mg
(USP Specs.)
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
143. TAZADIN 4 MG TABLETS. SN/QC/SAPP/040 QCM
Each Tablet Contains:
063460
Tizanidine as HCL……….4mg
(USP Specs.)
144. VINZ 250MG TABLETS SN/QC/SAPP/041 QCM
Each Tablet Contains:-
049381
Levofloxacin as Hemihydrates…250mg.
(SHAWAN Specs)
145. VINZ 500MG TABLETS SN/QC/SAPP/042 QCM
Each Tablet Contains:-
049382
Levofloxacin as Hemihydrates…500mg.
(SHAWAN Specs)
146. VIZZ 140MG TABLETS SN/QC/SAPP/043 QCM
Each Tablet Contains:-
049384 Artemether.......…………20mg.
Lumefantrine......………120mg.
(Shawan’s Specs)
147. VIZZ DS TABLETS SN/QC/SAPP/044 QCM
Each Tablet Contains:-
060180 Artemether.......…………40mg.
Lumefantrine......……..240mg.
(Shawan’s Specs)
148. XERON 550MG TABLETS. SN/QC/SAPP/045 QCM
Each Tablet Contains:
063464
Naproxen Sodium ……….550mg
(USP Specs.)
149. RESCLEAR 250MG TABLETS SN/QC/SAPP/046 QCM
Each tablet contains:
056393
Clarithromycin ……… 250 mg
(B.P Specs.)
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
150. RESCLEAR 500MG TABLETS SN/QC/SAPP/047 QCM
056394 Each tablet contains:
Clarithromycin ……… 500 mg
(B.P Specs.)
151. KAVYR 0.5MG TABLETS SN/QC/SAPP/048 QCM
Each tablet Contains:
063454
Entecavir as Monohydrate…….0.5mg.
(Shawan’s Specs.)
152. RAAY 20 MG TABLETS SN/QC/SAPP/049 QCM
Each Tablet Contains:
063461
Citalopram as HBr……….20mg.
(USP Specs.)
153. HETRIZINE 10MG TABS SN/QC/SAPP/050 QCM
Each Tablet Contains:
056386 Cetirizine.........10mg.
(B.P Specs.)

154. HECLOFEN 50MG TABLETS SN/QC/SAPP/051 QCM

Each Tablet Contains:
056384
Diclofenac sodium BP.......50mg.
(B.P Specs.)
155. HECLOFEN 75MG TABLETS SN/QC/SAPP/052 QCM
Each Tablet Contains:
056385
Diclofenac sodium BP........75mg.
(B.P Specs.)
156. SHAW 40MG TABLETS SN/QC/SAPP/053 QCM
Each Tablet Contains:
063458 Famotidine……….40mg.
(USP Specs.)

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Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
157. FOLYRON TABLETS SN/QC/SAPP/054 QCM
Each Tablet Contains:
Iron III Hydroxide Polymaltose
063462 Complex Eq. to. Elemental Iron……
100mg.
Folic Acid….0.35mg.
(Shawan’s Specs.)

158. AQPINE 500GM INJECTION SN/QC/SAPP/055 QCM

Each vial Contains:-
056395 Sterile Cefepime as
HCI.......................500mg
(UPS)
159. AQPINE 1GM INJECTION SN/QC/SAPP/056 QCM
Each vial Contains:-
049386 Sterile Cefepime as
HCI.......................1000mg
(UPS)
160. BIPED 2000MG INJECTION SN/QC/SAPP/057 QCM
Each Vial Contains:-
Cefoperazone as Sodium…..1000mg.
049395
Sulbactum as Sodium…..…..1000mg
(Shawan Specs)

161. HARIDONE 250MG INJECTION SN/QC/SAPP/58 QCM

Each vial contains
056396 Sterile Ceftazidime as pentahydrate …
250 mg
(USP)
162. 056397 HARIDONE 500MG INJECTION SN/QC/SAPP/059 QCM
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
Each vial contains
Sterile Ceftazidime as pentahydrate …
500 mg
(USP)
163. HARIDONE 1gm INJECTION SN/QC/SAPP/060 QCM
Each vial contains
056398 Sterile Ceftazidime as pentahydrate …1
gm
(USP)
164. SHAXONE 250MG INJECTION SN/QC/SAPP/061 QCM
Each Vial Contains:-
049390
Ceftriaxone as Sodium...250mg.
(USP Specs)
165. SHAXONE 500MG INJECTION SN/QC/SAPP/063 QCM
Each Vial Contains:-
Ceftriaxone as Sodium…500mg.
049391
(USP Specs)

166. SHAXONE 1000MG INJECTION SN/QC/SAPP/064 QCM

Each Vial Contains:-
049392
Ceftriaxone as Sodium.1000mg.
(USP Specs)
167. WADIN 1000 MG INJECTION SN/QC/SAPP/065 QCM
Each vial contains Cephradine
056404
As L- Arginine.... 1000 mg
(USP Specs)
168. 049394 BIPED 1000MG INJECTION SN/QC/SAPP/066 QCM
Each Vial Contains:-
Cefoperazone as Sodium…….500mg.
Sulbactum as Sodium.……..…..500mg.
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Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
(Shawan Specs)
169. ZYMACEF 500MG INJECTION SN/QC/SAPP/067 QCM
Each Vial Contains:-
049388
Cefotaxime as Sodium...500mg.
(USP Specs)
170. ZYMACEF 1000MG I INJECTION. SN/QC/SAPP/068 QCM
Each Vial Contains:-
049389 Cefotaxime as Sodium…1000mg.
(USP Specs)

171. ZYMACEF 250MG INJECTION SN/QC/SAPP/069 QCM

Each Vial Contains:-
049387
Cefotaxime as Sodium...250mg.
(USP Specs)
172. INDOSEF 250MG INJECTION SN/QC/SAPP/102 QCM
Each Vial Contains:-
099916
Ceftriaxone as Sodium...250mg.
(USP Specs)
173. INDOSEF 500MG INJECTION SN/QC/SAPP/103 QCM
Each Vial Contains:-
099917
Ceftriaxone as Sodium...500mg.
(USP Specs)
174. INDOSEF 1000MG INJECTION SN/QC/SAPP/104 QCM
Each Vial Contains:-
099918
Ceftriaxone as Sodium...1000mg.
(USP Specs)
175. 099919 EBOTUX 1G INJECTION SN/QC/SAPP/105 QCM
Each Vial Contains:-
Cefoperazone as Sodium…….500mg.

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Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
Sulbactum as Sodium.……..…..500mg.
(JP Specs)
176. EBOTUX 2G INJECTION SN/QC/SAPP/106 QCM
Each Vial Contains:-
Cefoperazone as Sodium…….1000mg.
099920
Sulbactum as Sodium.……..
…..1000mg.
(JP Specs)
177. CEXIME 100MG SUSPENSIONS. SN/QC/SAPP/070 QCM
Each 5mL Contains:-
049416
Cefixime asTrihydrate ………..100mg.
(USP Specs)
178. CEXIME 200MG SUSPENSIONS. SN/QC/SAPP/071 QCM
Each 5mL Contains:-
049417 Cefixime asTrihydrate ………..200mg.
(USP Specs)

179. STICK 125 MG SUSPENSIONS. SN/QC/SAPP/072 QCM

Each 5mL Contains:-
049412
Cephadroxil as Monohydrate….125mg.
(USP Specs)
180. STICK 250 MG SUSPENSIONS SN/QC/SAPP/073 QCM
Each 5mL Contains:-
049413
Cephadroxil as Monohydrate….250mg.
(USP Specs)
181. WADIN 125MG SUSPENSION SN/QC/SAPP/074 QCM
Each 5mL Contains:-
049410
Cephradine as Monohydrate….125mg.
(USP Specs)

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
182. WADIN 250 MG SUSPENSIONS. SN/QC/SAPP/075 QCM
049411 Each 5mL Contains:-
Cephradine as Monohydrate….250mg.
(USP Specs)
183. SHAFIX 125 MG SUSPENSIONS. SN/QC/SAPP/076 QCM
Each 5mL Contains:-
049414
Cefaclor as Monohydrate……..125mg.
(USP Specs)
184. SHAFIX 250 MG SUSPENSIONS. SN/QC/SAPP/077 QCM
Each 5mL Contains:-
049415
Cefaclor as Monohydrate……..250mg.
(USP Specs)
185. SHIME SUSPENSION. SN/QC/SAPP/78 QCM
Each 5mL Contains:-
049409 Cefpodoxime as Proxetil…….40mg.
(USP Specs)

186. SERWAN 50MG TABLETS. SN/QC/SAPP/79 QCM

Each Tablet Contains:-
078093
SERTRALINE HCl
=sertraline….50mg(BP Specs)
187. SERWAN 100MG TABLETS. SN/QC/SAPP/80 QCM
Each Tablet Contains:-
078094
SERTRALINE HCl
=sertraline….100mg(BP Specs)
188. WAROXETIN 20MG TABLETS. SN/QC/SAPP/81 QCM
Each Tablet Contains:-
078095
Paroxetine HCl Hemihydrates
=Paroxetine….20mg(BP Specs)

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
189. GODEP TABLETS 37.5 MG SN/QC/SAPP/82 QCM
080387 Each film coated Tablet Contains:
Venlafaxine HCl.....37.5mg
(USP Specs.)
190. GODEP TABLETS 75MG SN/QC/SAPP/83 QCM
Each film coated tablet contains:
080388 Venlafaxine HCl.....75mg
(USP Specs.)
191. RISS TABLETS 1MG SN/QC/SAPP/84 QCM
Each film coated tablet Contains:
080379
Risperidone.....….1 mg
(USP Specs.)
192. RISS TABLETS 2MG SN/QC/SAPP/85 QCM
Each film coated tablet Contains:
080378
Risperidone.....….2 mg
(USP Specs.)
193. RISS TABLETS 3MG SN/QC/SAPP/86 QCM
Each film coated tablet Contains:
080377
Risperidone.....….3 mg
(USP Specs.)
194. RISS TABLETS 4MG SN/QC/SAPP/87 QCM
Each film coated tablet Contains:
080376
Risperidone.....….4 mg
(USP Specs.)
195. MIRTAX TABLETS 15MG SN/QC/SAPP/088 QCM
Each film coated tablet contains:
080389
Mirtazapine.....15mg
(USP Specs.)
196. 080386 ONZE TABLETS 5MG SN/QC/SAPP/089 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
Each Tablet Contains:
Olanzapine.....….5mg
(USP Specs.)
197. ONZE TABLETS 10MG SN/QC/SAPP/090 QCM
Each Tablet Contains:
080385
Olanzapine.....….10mg
(USP Specs.)
198. ETAL TABLETS 200MG SN/QC/SAPP/091 QCM
Each film coated tablet Contains:
080380
Quetiapine as fumarate.....….200mg
(Shawan’s Specs)
199. ETAL TABLETS 100MG SN/QC/SAPP/092 QCM
Each film coated tablet Contains:
080381
Quetiapine as fumarate.....….100mg
(Shawan’s Specs)
200. SN/QC/SAPP/093 QCM
ERBRO TABLETS 50MG
Each film coated tablet Contains:
080383
Topiramate.....….50mg
(USP Specs)

201. SN/QC/SAPP/094 QCM

ERBRO TABLETS 25MG
Each film coated tablet Contains:
080384
Topiramate.....….25mg
(USP Specs.)

202. 074808 KOIB 200MG CAPSULES SN/QC/SAPP/095 QCM

Each Capsule Contains:
Celecoxib.....….200 mg
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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
(Shawan’s Specs.)
203. TNZE-F 3/25MG CAPSULES SN/QC/SAPP/096 QCM
Each Capsule Contains:
090016 Olanzapine.....….3 mg
Fluoxetine (as hydrochloride)…..25mg
(USP Specs.)
204. TNZE-F 6/25MG CAPSULES SN/QC/SAPP/097 QCM
Each Capsule Contains:
090017 Olanzapine.....….6 mg
Fluoxetine (as hydrochloride)…..25mg
(USP Specs.)
205. FLUNZEGO 150MG CAPSULES SN/QC/SAPP/098 QCM
Each Capsule Contains:
090018
Fluconazole.....….150 mg
(BP Specs.)
206. Gemflol TABLETS 320MG SN/QC/SAPP/099 QCM
Each Tablet Contains:
049376
Gemifloxacin as Mesylate.....….320mg
(USP Specs.)
207. Letbrst TABLETS 2.5MG SN/QC/SAPP/100 QCM
Each Tablet Contains:
093340
Letrozole.....….2.5mg
(USP Specs.)
208. ETAL TABLETS 25MG SN/QC/SAPP/101 QCM
Each film coated tablet Contains:
090174
Quetiapine as fumarate.....….25mg
(USP Specs)
209. 090170 Odipine TABLETS 5MG SN/QC/SAPP/102 QCM
Each Tablet Contains:

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
Amlodipine (as besylate).....….5mg
(USP Specs.)
210. Odipine TABLETS 10MG SN/QC/SAPP/103 QCM
Each Tablet Contains:
090171
Amlodipine (as besylate).....….10mg
(USP Specs.)
211. Odipine TABLETS 10/160MG SN/QC/SAPP/104 QCM
Each Tablet Contains:
090172 Amlodipine (as besylate).....….10mg
Valsartan.....….160mg
(USP Specs.)
212. Odipine TABLETS 5/160MG SN/QC/SAPP/105 QCM
Each Tablet Contains:
090173 Amlodipine (as besylate).....….5mg
Valsartan.....….160mg
(USP Specs.)
213. Odipine TABLETS 5/80MG SN/QC/SAPP/106 QCM
Each Tablet Contains:
090175 Amlodipine (as besylate).....….5mg
Valsartan.....….80mg
(USP Specs.)
214.
Quality Record List of Raw Material (Active)(File # 04)

S.NO AUTHOR
NAME
SOP CODE
215. ARTEMETHER SN/QC/SAPRM/001 Analyst/Q.C.M
216. AZITROMYCIN DIHYDRATE SN/QC/ SAPRM /002 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
217. CEFEPIME HCI SN/QC/ SAPRM /003 Analyst/Q.C.M
218. CEFACLOR MICRONIZED SN/QC/ SAPRM /004 Analyst/Q.C.M
219. CEFADROXIL MICRONIZED SN/QC/ SAPRM /005 Analyst/Q.C.M
220. CEFADROXIL COMPACTED SN/QC/ SAPRM /006 Analyst/Q.C.M
221. CEFIXIME TRIHYDRATE COMPACTED SN/QC/ SAPRM /007 Analyst/Q.C.M
222. CEFIXIME TRIHYDRATE MICRONIZED SN/QC/ SAPRM /008 Analyst/Q.C.M
223. CEFOPERAZONE SODIUM + SULBACTAUM SODIUM SN/QC/ SAPRM /009 Analyst/Q.C.M
224. CEFPODOXIME PROXETIL COMPACTED SN/QC/ SAPRM /010 Analyst/Q.C.M
225. CEFPODOXIME PROXETIL MICRONIZED SN/QC/ SAPRM /011 Analyst/Q.C.M
226. CEFOTAXIME SODIUM SN/QC/ SAPRM /012 Analyst/Q.C.M
227. CEFTAZIDIME PEHTAHYDRATE SN/QC/ SAPRM /013 Analyst/Q.C.M
228. CEFTRIAXONE SODIUM SN/QC/ SAPRM /014 Analyst/Q.C.M
229. CEPHRADINE MONOHYDRATE COMPACTED SN/QC/ SAPRM /015 Analyst/Q.C.M
230. CEPHRADINE MONOHYDRATE MICRONIZED SN/QC/ SAPRM /016 Analyst/Q.C.M
231. CETRIZINE DIHYDRCHLORIDE SN/QC/ SAPRM /017 Analyst/Q.C.M
232. CIPROFLOXACIN HYDROCHLORIDE SN/QC/ SAPRM /018 Analyst/Q.C.M
233. CITALOPRAM HBr SN/QC/ SAPRM /019 Analyst/Q.C.M
234. CLARITHROMYCIN SN/QC/ SAPRM /020 Analyst/Q.C.M
235. CLOZAPINE SN/QC/ SAPRM /021 Analyst/Q.C.M
236. DICLOFENAC POTASSIUM SN/QC/ SAPRM /022 Analyst/Q.C.M
237. DICLOFENAC SODIUM SN/QC/ SAPRM /023 Analyst/Q.C.M
238. ENTECAVIR MONOHYDRATE SN/QC/ SAPRM /024 Analyst/Q.C.M
239. ESCITALOPRAM OXALATE SN/QC/ SAPRM /025 Analyst/Q.C.M
240. ESOMEPRAZOLE MAGNESIUM 8.5% PELLTES SN/QC/ SAPRM /026 Analyst/Q.C.M
241. FAMOTIDINE SN/QC/ SAPRM /027 Analyst/Q.C.M
242. FLOUXETINE HYDROCHLORIDE SN/QC/ SAPRM /028 Analyst/Q.C.M
243. FOLIC ACID SN/QC/ SAPRM /029 Analyst/Q.C.M
244. GLIMEPIRIDE SN/QC/ SAPRM /030 Analyst/Q.C.M
245. IROM III HYDROXIDE POLYMALTOSE COMPLEX SN/QC/ SAPRM /031 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
246. ISOTRETINOIN SN/QC/ SAPRM /032 Analyst/Q.C.M
247. LANSOPRAZOLE 8.5%PELLETS SN/QC/ SAPRM /033 Analyst/Q.C.M
248. LEVOCETRIZINE DIHYDROCHLORIDE SN/QC/ SAPRM /034 Analyst/Q.C.M
249. LEVOFLOXACIN HEMIHYDRATE SN/QC/ SAPRM /035 Analyst/Q.C.M
250. LORATIDINE SN/QC/ SAPRM /036 Analyst/Q.C.M
251. LUMEFANTRINE SN/QC/ SAPRM /037 Analyst/Q.C.M
252. MECOBALAMIN SN/QC/ SAPRM /038 Analyst/Q.C.M
253. MELOXICAM SN/QC/ SAPRM /039 Analyst/Q.C.M
254. MIRTAZAPINE SN/QC/ SAPRM /040 Analyst/Q.C.M
255. MONTELOKAST SODIUM SN/QC/ SAPRM /041 Analyst/Q.C.M
256. NAPROXEN SODIUM SN/QC/ SAPRM /042 Analyst/Q.C.M
257. OFLOXACIN SN/QC/ SAPRM /043 Analyst/Q.C.M
258. OLANZAPINE SN/QC/ SAPRM /044 Analyst/Q.C.M
259. OMEPRAZOLE 8.5% PELLTES SN/QC/ SAPRM /045 Analyst/Q.C.M
260. PENTOPRAZOLE SODIUM SN/QC/ SAPRM /046 Analyst/Q.C.M
261. PAROXETINE HYDROCHLORIDE HEMIHYDRATE SN/QC/ SAPRM /047 Analyst/Q.C.M
262. PIROXICAM SN/QC/ SAPRM /048 Analyst/Q.C.M
263. PIROXICAM BETA CYCLODEXTRIN SN/QC/ SAPRM /049 Analyst/Q.C.M
264. QUETIAPINE FUMARATE SN/QC/ SAPRM /050 Analyst/Q.C.M
265. RISPERIDONE SN/QC/ SAPRM /051 Analyst/Q.C.M
266. SERTRALINE HYDROCHLORDIE SN/QC/ SAPRM /052 Analyst/Q.C.M
267. SOFOSBUVIR SN/QC/ SAPRM /053 Analyst/Q.C.M
268. TIZANIDINE HYDROCHLORIDE SN/QC/ SAPRM /054 Analyst/Q.C.M
269. TOPIRAMATE SN/QC/ SAPRM /055 Analyst/Q.C.M
270. VENLAFAXINE HYDROCHLORIDE SN/QC/ SAPRM /056 Analyst/Q.C.M
271. GEMIFLOXACIN SN/QC/ SAPRM /057 Analyst/Q.C.M
272. FLUCONAZOLE SN/QC/ SAPRM /058 Analyst/Q.C.M
273. LETROZOLE SN/QC/ SAPRM /059 Analyst/Q.C.M
274. CELECOXIB SN/QC/ SAPRM /060 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
275. CHLOROQUINE PHOSPHATE SN/QC/SAPRM/061 Analyst/Q.C.M
276. HYDROXYCHLOROQUINE SULFATE SN/QC/SAPRM/062 Analyst/Q.C.M
277. OSELTAMIVIR SN/QC/SAPRM/063 Analyst/Q.C.M
278. RITONAVIR SN/QC/SAPRM/064 Analyst/Q.C.M
279. LOPINAVIR SN/QC/SAPRM/065 Analyst/Q.C.M
280. ASCORBIC ACID SN/QC/SAPRM/066 Analyst/Q.C.M
281. TENOFOVIR DISOPROXIL SN/QC/SAPRM/067 Analyst/Q.C.M
282. TACROLIMUS SN/QC/SAPRM/068 Analyst/Q.C.M
283. MIKOFENOLAT MOFETIL SN/QC/SAPRM/069 Analyst/Q.C.M
284. VALSARTAN SN/QC/SAPRM/070 Analyst/Q.C.M
285. AMLODIPINE BESYLATE SN/QC/SAPRM/071 Analyst/Q.C.M
286. ESOMEPRAZOLE PELLETS 22.5% SN/QC/SAPRM/072 Analyst/Q.C.M

Quality Record List of Raw Material (Non-Active) (File # 03)

S.NO NAME AUTHOR

SOP CODE
287. AVICEL PH 102 SN/QC/SAPRM/001 Analyst/Q.C.M
288. CABOSIL M5(AEROSIL 200) SN/QC/ SAPRM /002 Analyst/Q.C.M
289. CAPSULE SHELL ORANGE # 02 SN/QC/ SAPRM /003 Analyst/Q.C.M
290. CAPSULES SHELL BLUE/BLUE #0 SN/QC/ SAPRM /004 Analyst/Q.C.M
291. CAPSULES SHELL WHITE#1 SN/QC/ SAPRM /005 Analyst/Q.C.M
292. CAPSULES SHELL P.BLUE #2 SN/QC/ SAPRM /006 Analyst/Q.C.M
293. CITRIC ACID SN/QC/ SAPRM /007 Analyst/Q.C.M
294. CMC SODIUM SN/QC/ SAPRM /008 Analyst/Q.C.M
295. COATDRY MS SN/QC/ SAPRM /009 Analyst/Q.C.M
296. COATDRY 2200 SN/QC/ SAPRM /010 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
297. COATDRY ENTERIC SN/QC/ SAPRM /011 Analyst/Q.C.M
298. COATDRY WHITE AQUEOUS SN/QC/ SAPRM /012 Analyst/Q.C.M
299. COLOR ERYTHROCIN RED SN/QC/ SAPRM /013 Analyst/Q.C.M
300. COLOR AMARANTH SN/QC/ SAPRM /014 Analyst/Q.C.M
301. COLOR APPLE GREEN W/S SN/QC/ SAPRM /015 Analyst/Q.C.M
302. ASPARTAME SN/QC/ SAPRM /016 Analyst/Q.C.M
303. COLOR PONCEAU RED SN/QC/ SAPRM /017 Analyst/Q.C.M
304. COLOR QUINOLONE YELLOW SN/QC/ SAPRM /018 Analyst/Q.C.M
305. COLOR TARTRAZINE YELLOW W/S SN/QC/ SAPRM /019 Analyst/Q.C.M
306. COLOR TARTRAZINE LAKE SN/QC/ SAPRM /020 Analyst/Q.C.M
307. CROSCARMELLOSE SODIUM SN/QC/ SAPRM /021 Analyst/Q.C.M
308. FLAVOR ORANGE SN/QC/ SAPRM /022 Analyst/Q.C.M
309. FLAVOR PINE APPLE SN/QC/ SAPRM /023 Analyst/Q.C.M
310. FLAVOR BANANA SN/QC/ SAPRM /024 Analyst/Q.C.M
311. FLAVOR CHOCOLATE SN/QC/ SAPRM /025 Analyst/Q.C.M
312. FLAVOR RASPBERRY SN/QC/ SAPRM /026 Analyst/Q.C.M
313. FLAVOR STRAWBERRY SN/QC/ SAPRM /027 Analyst/Q.C.M
314. IPA SN/QC/ SAPRM /028 Analyst/Q.C.M
315. LACTOSE SN/QC/ SAPRM /029 Analyst/Q.C.M
316. Color chocolate SN/QC/ SAPRM /038 Analyst/Q.C.M
317. SODIUM BENZOATE SN/QC/ SAPRM /039 Analyst/Q.C.M
318. SODIUM SACCHARINE SN/QC/ SAPRM /040 Analyst/Q.C.M
319. STARCH SN/QC/ SAPRM /041 Analyst/Q.C.M
320. SUCROSE SN/QC/ SAPRM /042 Analyst/Q.C.M
321. TALCUM PURIFIED SN/QC/ SAPRM /043 Analyst/Q.C.M
322. TiO2 SN/QC/ SAPRM /044 Analyst/Q.C.M
323. WATER FOR INJECTION SN/QC/ SAPRM /045 Analyst/Q.C.M
324. XANTHAN GUM SN/QC/ SAPRM /046 Analyst/Q.C.M
325. SODIUM BENZOATE SN/QC/SAPRM/047 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
326. Color chocolate SN/QC/ SAPRM /038 Analyst/Q.C.M

PACKING MATERIAL (UNIT-CARTON) (File #08, 09, 10)

SR. NAME SOP NO Maintain by
327. SHAXONE 250MG INJ SN/QC/SAPPM/001 Analyst/Q.C.M
328. SHAXONE 500MG INJ SN/QC/SAPPM/002 Analyst/Q.C.M
329. SHAXONE 1000MG INJ SN/QC/SAPPM/003 Analyst/Q.C.M
330. ZYMACEF 250MG INJ SN/QC/SAPPM/004 Analyst/Q.C.M
331. ZYMACEF 500MG INJ SN/QC/SAPPM/005 Analyst/Q.C.M
332. ZYMACEF 1000MG INJ SN/QC/SAPPM/006 Analyst/Q.C.M
333. BIPED 1GM INJ SN/QC/SAPPM/007 Analyst/Q.C.M
334. BIPED 1GM INJ(P/S) SN/QC/SAPPM/008 Analyst/Q.C.M
335. BIPED 2GM INJ SN/QC/SAPPM/009 Analyst/Q.C.M
336. BIPED 2GM INJ (P/S) SN/QC/SAPPM/010 Analyst/Q.C.M
337. AQPINE 1GM INJ SN/QC/SAPPM/011 Analyst/Q.C.M
338. VIZZ 140MG TABS SN/QC/SAPPM/013 Analyst/Q.C.M
339. P-SESQ 40MG TABS SN/QC/SAPPM/014 Analyst/Q.C.M
340. FITCID 30MG CAP SN/QC/SAPPM/015 Analyst/Q.C.M
341. BANXIN 250MG TABS SN/QC/SAPPM/016 Analyst/Q.C.M
342. BANXIN 500MG TABS SN/QC/SAPPM/017 Analyst/Q.C.M
343. CEXIME 400MG CAPS SN/QC/SAPPM/018 Analyst/Q.C.M
344. CEXIME 400MG CAPS (P/S) SN/QC/SAPPM/019 Analyst/Q.C.M
345. OMEYZ CAPS SN/QC/SAPPM/020 Analyst/Q.C.M
346. SHAEZ 20MG CAPS SN/QC/SAPPM/021 Analyst/Q.C.M
347. SHAEZ 40MG CAPS SN/QC/SAPPM/022 Analyst/Q.C.M
348. SHAFLO 200MG TABS SN/QC/SAPPM/023 Analyst/Q.C.M
349. SHAPRAM 10MG TABS SN/QC/SAPPM/024 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
350. VINZ 250 MG TABS SN/QC/SAPPM/025 Analyst/Q.C.M
351. VINZ 500 MG TABS SN/QC/SAPPM/026 Analyst/Q.C.M
352. XEGTIN 20MG APS SN/QC/SAPPM/027 Analyst/Q.C.M
353. ZITON 250MG TABS SN/QC/SAPPM/028 Analyst/Q.C.M
354. LYMFO CAPS SN/QC/SAPPM/029 Analyst/Q.C.M
355. SHAWBAL CAPS SN/QC/SAPPM/030 Analyst/Q.C.M
356. CEXIME 100MG/5ML D/S SN/QC/SAPPM/031 Analyst/Q.C.M
357. XEGEN 20MG CAPS SN/QC/SAPPM/032 Analyst/Q.C.M
358. CEXIME 100MG/5ML D/S(P/S) SN/QC/SAPPM/033 Analyst/Q.C.M
359. CEXIME 200MG/5ML D/S SN/QC/SAPPM/034 Analyst/Q.C.M
360. CEXIME 200MG/5ML D/S P/S SN/QC/SAPPM/035 Analyst/Q.C.M
361. TAZADIN 4MG TABS SN/QC/SAPPM/113 Analyst/Q.C.M
362. TAZADIN 2MG TABS SN/QC/SAPPM/194 Analyst/Q.C.M
363. AMIZIP 100MG TABS SN/QC/SAPPM/112 Analyst/Q.C.M
364. AMIZIP 25 MG TABS SN/QC/SAPPM/160 Analyst/Q.C.M
365. TEROX 250MG CAPS SN/QC/SAPPM/159 Analyst/Q.C.M
366. TEROX 500MG TABS SN/QC/SAPPM/158 Analyst/Q.C.M
367. OMARID 1MG TABS SN/QC/SAPPM/157 Analyst/Q.C.M
368. OMARID 2MG TABS SN/QC/SAPPM/156 Analyst/Q.C.M
369. OMARID 3MG TABS SN/QC/SAPPM/155 Analyst/Q.C.M
370. OMARID 4MG TABS SN/QC/SAPPM/168 Analyst/Q.C.M
371. XERON 550MG TABS SN/QC/SAPPM/169 Analyst/Q.C.M

PACKING MATERIAL (LEAFLETS) (File #13)

372. SHAXONE 250MG INJ SN/QC/SAPPM/036 Analyst/Q.C.M
373. SHAXONE 500MG INJ SN/QC/SAPPM/037 Analyst/Q.C.M
374. SHAXONE 1000MG INJ SN/QC/SAPPM/038 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
375. ZYMACEF 250MG INJ SN/QC/SAPPM/039 Analyst/Q.C.M
376. ZYMACEF 500MG INJ SN/QC/SAPPM/040 Analyst/Q.C.M
377. ZYMACEF 1000MG INJ SN/QC/SAPPM/041 Analyst/Q.C.M
378. BIPED 1GM INJ SN/QC/SAPPM/042 Analyst/Q.C.M
379. BIPED 1GM INJ(P/S) SN/QC/SAPPM/043 Analyst/Q.C.M
380. BIPED 2GM INJ SN/QC/SAPPM/044 Analyst/Q.C.M
381. BIPED 2GM INJ (P/S) SN/QC/SAPPM/045 Analyst/Q.C.M
382. AQPINE 1GM INJ SN/QC/SAPPM/046 Analyst/Q.C.M
383. VIZZ 140MG TABS SN/QC/SAPPM/047 Analyst/Q.C.M
384. P-SESQ 40MG TABS SN/QC/SAPPM/048 Analyst/Q.C.M
385. FITCID 30MG CAP SN/QC/SAPPM/049 Analyst/Q.C.M
386. BANXIN 250MG TABS SN/QC/SAPPM/050 Analyst/Q.C.M
387. BANXIN 500MG TABS SN/QC/SAPPM/051 Analyst/Q.C.M
388. CEXIME 400MG CAPS SN/QC/SAPP M/052 Analyst/Q.C.M
389. CEXIME 400MG CAPS (P/S) SN/QC/SAPPM/053
390. OMEYZ CAPS SN/QC/SAPPM/054 Analyst/Q.C.M
391. SHAEZ 20MG CAPS SN/QC/SAPM/055 Analyst/Q.C.M
392. SHAEZ 40MG CAPS SN/QC/SAPPM/056 Analyst/Q.C.M
393. SHAFLO 200MG TABS SN/QC/SAPPM/057 Analyst/Q.C.M
394. SHAPRAM 10MG TABS SN/QC/SAPPM/058 Analyst/Q.C.M
395. VINZ 250 MG TABS SN/QC/SAPPM/059 Analyst/Q.C.M
396. VINZ 500 MG TABS SN/QC/SAPPM/060 Analyst/Q.C.M
397. XEGTIN 20MG APS SN/QC/SAPPM/061 Analyst/Q.C.M
398. ZITON 250MG TABS SN/QC/SAPPM/062 Analyst/Q.C.M
399. LYMFO CAPS SN/QC/SAPPM/063 Analyst/Q.C.M
400. SHAWBAL CAPS SN/QC/SAPPM/064 Analyst/Q.C.M
401. CEXIME 100MG/5ML D/S SN/QC/SAPPM/065 Analyst/Q.C.M
402. XEGEN 20MG CAPS SN/QC/SAPPM/066 Analyst/Q.C.M
403. CEXIME 100MG/5ML D/S(P/S) SN/QC/SAPPM/067 Analyst/Q.C.M

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
404. CEXIME 200MG/5ML D/S SN/QC/SAPPM/068 Analyst/Q.C.M
405. CEXIME 200MG/5ML D/S P/S SN/QC/SAPPM/069 Analyst/Q.C.M
406. TAZADIN 4MG TABS SN/QC/SAPPM/070 Analyst/Q.C.M
407. TAZADIN 2MG TABS SN/QC/SAPPM/071 Analyst/Q.C.M
408. AMIZIP 100MG TABS SN/QC/SAPPM/072 Analyst/Q.C.M
409. AMIZIP 25 MG TABS SN/QC/SAPPM/073 Analyst/Q.C.M
410. TEROX 250MG CAPS SN/QC/SAPPM/074 Analyst/Q.C.M
411. TEROX 500MG TABS SN/QC/SAPPM/075 Analyst/Q.C.M
412. OMARID 1MG TABS SN/QC/SAPPM/076 Analyst/Q.C.M
413. OMARID 2MG TABS SN/QC/SAPPM/077 Analyst/Q.C.M
414. OMARID 3MG TABS SN/QC/SAPPM/078 Analyst/Q.C.M
415. OMARID 4MG TABS SN/QC/SAPPM/079 Analyst/Q.C.M
416. XERON 550MG TABS SN/QC/SAPPM/080 Analyst/Q.C.M

PACKING MATERIAL (ALUM-FOIL) (File # 12)

417. FITCID 30MG CAP SN/QC/SAPPM/074 Analyst/Q.C.M

418. BANXIN 250MG TABS SN/QC/SAPPM/075 Analyst/Q.C.M
419. BANXIN 500MG TABS SN/QC/SAPPM/076 Analyst/Q.C.M
420. CEXIME 400MG CAPS SN/QC/SAPPM/077 Analyst/Q.C.M
421. CEFGEN 400MG CAPS SN/QC/SAPPM/188 Analyst/Q.C.M
422. ZANXIM 400MG CAPS SN/QC/SAPPM/187 Analyst/Q.C.M
423. HETRIZINE 10MG TABS SN/QC/SAPPM/181 Analyst/Q.C.M
424. SEPRETINE CAPS SN/QC/SAPPM/185 Analyst/Q.C.M

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
425. HARICAM 7.5MG TABS SN/QC/SAPPM/125 Analyst/Q.C.M
426. HECLOFEN 50MG TABS SN/QC/SAPPM/130 Analyst/Q.C.M
427. HARICAM 15MG TABS SN/QC/SAPPM/126 Analyst/Q.C.M
428. SHAEZ 20MG CAPS SN/QC/SAPPM/078 Analyst/Q.C.M
429. SHAEZ 40MG TABS SN/QC/SAPPM/079 Analyst/Q.C.M
430. VINZ 500MG TABS SN/QC/SAPPM/084 Analyst/Q.C.M
431. HECLOFEN 75MG TABS SN/QC/SAPPM/130 Analyst/Q.C.M
432. MONAZ 5MG TABS SN/QC/SAPPM/127 Analyst/Q.C.M
433. MONAZ 10MG TABS SN/QC/SAPPM/128 Analyst/Q.C.M
434. RESCLAER 500MG TABS SN/QC/SAPPM/129 Analyst/Q.C.M
435. WADIN 500MG CAPS SN/QC/SAPPM/132 Analyst/Q.C.M
436. OMEYZ 20MG CAPS SN/QC/SAPPM/076 Analyst/Q.C.M
437. LYMFO CAPS SN/QC/SAPPM/075 Analyst/Q.C.M
438. XEGTIN 20MG CAPS SN/QC/SAPPM/087 Analyst/Q.C.M
439. SHAFLO 200MG TABS SN/QC/SAPPM/080 Analyst/Q.C.M
440. SAPRAM 10MG TABS SN/QC/SAPPM/081 Analyst/Q.C.M
441. ZITON 250MG CAPS SN/QC/SAPPM/088 Analyst/Q.C.M
442. XEGEN 20MG CAPS SN/QC/SAPPM/086 Analyst/Q.C.M
443. VINZ 250MG TABS SN/QC/SAPPM/083 Analyst/Q.C.M
444. SHAWBAL CAPS SN/QC/SAPPM/082 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
445. TAZADIN 4MG TABS SN/QC/SAPPM/084 Analyst/Q.C.M
446. TAZADIN 2MG TABS SN/QC/SAPPM/085 Analyst/Q.C.M
447. AMIZIP 100MG TABS SN/QC/SAPPM/086 Analyst/Q.C.M
448. AMIZIP 25 MG TABS SN/QC/SAPPM/087 Analyst/Q.C.M
449. TEROX 250MG CAPS SN/QC/SAPPM/088 Analyst/Q.C.M
450. TEROX 500MG TABS SN/QC/SAPPM/089 Analyst/Q.C.M
451. OMARID 1MG TABS SN/QC/SAPPM/090 Analyst/Q.C.M
452. OMARID 2MG TABS SN/QC/SAPPM/091 Analyst/Q.C.M
453. OMARID 3MG TABS SN/QC/SAPPM/092 Analyst/Q.C.M
454. OMARID 4MG TABS SN/QC/SAPPM/093 Analyst/Q.C.M
455. XERON 550MG TABS SN/QC/SAPPM/094 Analyst/Q.C.M
456. NEAMIN TABS SN/QC/SAPPM/0 Analyst/Q.C.M
457. PYZED TABS SN/QC/SAPPM/0 Analyst/Q.C.M

PACKING MATERIAL (LABELS) (FILE# 11)

458. Cexime 100mg/5ml Suspension SN/QC/SAPPM/001 Analyst/Q.C.M
459. Cexime 100mg/5ml SN/QC/SAPPM/002 Analyst/Q.C.M
Suspension(P/S)
460. Cexime 200mg/5ml Suspension SN/QC/SAPPM/003 Analyst/Q.C.M
461. Wadin 250mg/5ml Suspension SN/QC/SAPPM/005 Analyst/Q.C.M
462. Wadin 125mg/5ml Suspension SN/QC/SAPPM/006 Analyst/Q.C.M
463. Shafix 125mg/5ml Suspension SN/QC/SAPPM/007 Analyst/Q.C.M

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
464. Shafix 250mg/5ml Suspension SN/QC/SAPPM/008 Analyst/Q.C.M
465. Shime 40 mg Suspension SN/QC/SAPPM/009 Analyst/Q.C.M
466. Stick 125mg/5ml Suspension SN/QC/SAPPM/010 Analyst/Q.C.M
467. Stick 250mg/5ml Suspension SN/QC/SAPPM/011 Analyst/Q.C.M
468. Aqpine 1000mg Injection SN/QC/SAPPM/012 Analyst/Q.C.M
469. Aqpine 500mg Injection SN/QC/SAPPM/113 Analyst/Q.C.M
470. Biped 1000mg Injection SN/QC/SAPPM/014 Analyst/Q.C.M
471. Biped 1000mg Injection P/S SN/QC/SAPPM/015 Analyst/Q.C.M
472. Biped 2000mg Injection SN/QC/SAPPM/016 Analyst/Q.C.M
473. Biped 2000mg Injection P/S SN/QC/SAPPM/017 Analyst/Q.C.M
474. Haridone 500mg Injection SN/QC/SAPPM/018 Analyst/Q.C.M
475. Haridone 250mg Injection SN/QC/SAPPM/019 Analyst/Q.C.M
476. Haridone 1000mg Injection SN/QC/SAPPM/020 Analyst/Q.C.M
477. Shaxone 250 mg Injection SN/QC/SAPPM/021 Analyst/Q.C.M
478. Shaxone 500mg Injection SN/QC/SAPPM/022 Analyst/Q.C.M
479. Shaxone 1000mg Injection SN/QC/SAPPM/023 Analyst/Q.C.M
480. Zymacef 250mg Injection SN/QC/SAPPM/024 Analyst/Q.C.M
481. Zymacef 500mg Injection SN/QC/SAPPM/025 Analyst/Q.C.M
482. Zymacef 1000mg Injection SN/QC/SAPPM/026 Analyst/Q.C.M

JOB DESCRIPTION (File # 19)

Document Code Maintain by Location Retention Period

S.No Document Name
483. Job Description for Director Operation SN/JD/001 Q.C.M Management As per Revision
484. Job Description for P.M SN/JD/002 PM cell
Production As per Revision
485. Job Description for quality Control manager SN/JD/003 Q.C.M Office
Qc Lab As per Revision

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
486. Job Description for Raw Material Store SN/JD/004 PM Production As per
Office Revision
487. Job Description for Incharge ware house SN/JD/005 PM Production As per Revision
Office
488. Job Description for Maintenance Incharge SN/JD/006 PM Production As per Revision
Office
489. Job Description For Microbiologist SN/JD/007 Q.C.M Qc Lab As per Revision

490. Job Description for Operator Blister SN/JD/008 PM & Section In Production
As per Revision
charge Office
491. Job Description for Operator Capsules SN/JD/009 PM & Section In Production
charge Office As per Revision

492. Job Description for Operator Coating SN/JD/010 PM & Section In Production
charge Office As per Revision

493. Job Description for Operator Dry Powder SN/JD/011 PM & Section In Production
Suspension charge office As per Revision

494. Job Description for Operator Dry Powder SN/JD/012 PM & Section In Production
Injection charge Office As per Revision

495. Job Description for Operator Laser Jet Printer SN/JD/013 PM & Section In Production As per Revision
Charge Office
496. Job Description for Operator Tablet Section SN/JD/014 PM & Section In Production As per Revision
charge office
497. Job Description for Packing In charge SN/JD/015 PM & Section In Production As per Revision
Charge Office
498. Job Description for In Charge Finished SN/JD/016 Production
Good Store PM Office As per Revision

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
499. Job Description for Pharmacist Capsule SN/JD/017 Production As per
PM
Office Revision
500. Job Description for Pharmacist Sterile Area SN/JD/018 PM Production As per Revision
501. Job Description for Pharmacist Dry Powder SN/JD/019 Production
Suspension PM As per Revision

502. Job Description for Pharmacist Tablets SN/JD/020 Production

PM Office As per Revision

503. MR/FIN. Management

JD FOR Purchase Officer As per updating
SN/JD/021 cell
MANAGER
504. Job Description for In charge Packing Material SN/JD/022 PM & Section In Production
As per Revision
Store Charge Office
505. Job Description For Validation Officer SN/JD/023
Q.C.M Qc Lab As per Revision

506. Job Description For Quality Control SN/JD/024

Q.C.M Qc Lab As per Revision
Officer/Analyst
507. Job Description For Quality Control Lab SN/JD/025
Q.C.M Qc Lab As per Revision
Attendant
508. MR/FIN. Management
JD FOR FINANCE MANAGER As per updating
SN/JD/FIN/001 cell/Fin. office
MANAGER
509. JD FOR ACCOUNTANT MR/FIN. Management As per updating
SN/JD/FIN/002 MANAGER cell/Fin. office
510. JD FOR NETWORK ADMINISTRATOR Management As per updating
SN/JD/FIN/003 MR/FIN.MANAGER
cell/Fin. office

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
511. JD FOR ACCOUNTS OFFICER SN/JD/FIN/004 MR/FIN.MANAGER Management As per
cell/Fin. office updating

FORMATS OF DOCUMENTS ( FILE # 18)

S.NO DOCUMENT NAME DOCUMENT CODE AUTHOR
512. CERTIFICATE OF ANALYSIS FINISHED PRODUCTS QRF 001 QCM
513. CERTIFICATE OF ANALYSIS PACKING MATERIAL QRF 002 QCM
514. CERTIFICATE OF ANALYSIS RAW MATERIAL QRF 003 QCM
515. STERILITY TEST REPORT QRF 004 QCM
516. CERTIFICATE OF ANALYSIS TABLETS / CAPSULES QRF 005 QCM
517. WORK SHEET QRF 006 QCM
518. CERTIFICATE OF ANALYSIS DRY POWDER INJECTION QRF 007 QCM
519. CERTIFICATE OF ANALYSIS DRY SUSPENSION QRF 008 QCM
520. CERTIFICATE OF ANALYSIS BACTERIAL QRF 009 QCM
ENDOTOXINS
521. GROWTH PROMOTION REPORT QRF 010 QCM
522. PRODUCT STABILITY STUDY (ACCELERATED) QRF 011 QCM
523. TRIAL BATCH CARD QRF 012 QCM
524. PRODUCT STABILITY STUDY(LONG TERM) QRF 013 QCM
525. AREA MONITORING (MICROBIOLOGY QRF 014 QCM
LAB)
526. BALANCE CALIBRATION QRF 016 QCM
527. BATCH HISTORY CHECK LIST QRF 017 QCM
528. CERTIFIACATE OF ANLAYSIS R.O WATER QRF 018 QCM
529. CUSTOMER COMPLAINT LOG BOOK QRF 019 QCM
530. CUSTOMER COMPLAINT FORM QRF 020 QCM
531. DAILY INSPECTION REPORT QRF 021 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
532. DOCUMENT CHANGE FORM QRF 022 QCM
533. STERILE AREA PARTICLE COUNTER QRF 023 QCM
534. INJECTABLE MACHINARY AND PERSONAL GEAR QRF 024 QCM
MONITORING
535. VALIDATION REPORT FOR ASEPTIC GOWNING QRF 025 QCM
536. INTERNAL CALIBRATION CERTIFICATE QRF 026 QCM
537. MEDIA PREPARATION AND GROWTH PROMOTION QRF 027 QCM
RECORD
538. MONITORING OF HEPA FILTERS (MICRO) QRF 028 QCM
539. AREA MONITORING REPORT ORAL QRF 029 QCM
540. PRODUCT RECALL FORM QRF 030 QCM
541. MONITORING OF HEPA FILTERS (STERILE AREA) QRF 031 QCM
542. PACKING CHECK LIST QRF 032 QCM
543. PH METER CALIBRATION SHEET QRF 033 QCM
544. PRODUCT DISPOSAL FORM QRF 034 QCM
545. REQUEST FOR ANALYSIS QRF 035 QCM
546. STABILITY CHAMBER MONITORING QRF 036 QCM
547. LAL TEST VALIDATION QRF 037 QCM
548. LAL REAGENT VALIDATION FORM QRF 038 QCM
549. STERILITY TEST VALIDATION QRF 039 QCM
550. CALIBRATION CERTIFICATE VOLUMETRIC FLASKS QRF 040 QCM
551. CALIBRATION CERTIFICATE BURETTS QRF 041 QCM
552. KARL FISCHER CALIBRATION QRF 042 QCM
553. CALIBRATION OF DT APPARATUS QRF 043 QCM
554. CALIBRATION OF DISSOLUTION APPARATUS QRF 044 QCM
555. MOISTURE ANAYZER LOG BOOK QRF/QC/001 QCM
556. KARL FISCHER LOG BOOK QRF/QC/002 QCM
557. UV SPECTROPHOTOMETER LOG BOOK QRF/QC/003 QCM
558. ANALYTICAL BALANCE LOG BOOK QRF/QC/004 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
559. HPLC LOG BOOK QRF/QC/005 QCM
560. DISSOLUTION APPARATUS LOG BOOK QRF/QC/006 QCM
561. DT APPARATUS LOG BOOK QRF/QC/007 QCM
562. FRIABILITY LOG BOOK QRF/QC/008 QCM
563. HARDNESS TESTER LOG BOOK QRF/QC/009 QCM
564. pH METER LOG BOOK QRF/QC/010 QCM
565. OOS LOGBOOK QRF/QC/011 QCM
566. POLARIMETER LOGBOOK QRF/QC/012 QCM
567. MELTING POINT APPARATUS LOGBOOK QRF/QC/013 QCM
568. SWAB TEST LOGBOOK QRF/QC/014 QCM
569. REAGENTS APPARATUS LOGBOOK QRF/QC/015 QCM
570. CONDUCTIVITY & TDS METER QRF/QC/016 QCM
571. QC DAILY ACTIVITIES LOGBOOK QRF/QC/017 QCM
572. Q.C # PACKING MATERIAL LOG BOOK QRF 053 QCM
573. Q.C # PRODUCTS LOG BOOK QRF 054 QCM
574. Q.C # RAW MATERIAL LOG BOOK QRF 055 QCM
575. RAW MATERIAL APPROVAL LOG BOOK QRF 056 QCM
576. REAGENT LOG BOOK QRF 057 QCM
577. RETAINED SAMPLES LOG BOOK QRF 058 QCM
578. WASTE OF USED MEDIA LOG BOOK QRF 060 QCM
579. AUTOCLAVE LOG BOOK QRF 062 QCM
580. BATCH NUMBER LOG BOOK QRF 064 QCM
581. CLEANING VALIDATION FORM QRF 065 QCM
582. BATCH ANALYTICAL RECORD QRF 066 QCM
583. HOT INCUBATOR LOG BOOK QRF 067 QCM
584. COOL INCUBATOR LOG BOOK QRF 068 QCM
585. AUTOCLAVE LOOG BOOK QRF 069 QCM
586. MEDIA PREPARATION LOG BOOK QRF 070 QCM
587. AIR SAMPLER LOOG BOOK QRF 071 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
588. PASSIVIZATION RECORD QRF 072 QCM
589. ACCELERATED STABILITY TESTING QRF/QC/073 QCM
590. LONG TERM STABILITY TESTING QRF/QC/074 QCM
591. FUMIGATION RECORD QRF/QC/075 QCM
592. CHANGE CONTROL FORM MR/R/001 QCM
593. QUALITY RECORD LIST MR/R/002 QCM
594. CIRCULATION RECORD MR/R/003 QCM
595. CIRCULATION RECORD MR/R/004 QCM
596. MANAGEMENT REVIEW MEETING MR/R/005 QCM
597. INTER OFFICE CORESPONDENCE MR/R/006 QCM
598. TRAINING REQUEST FORM MR/R/007 QCM
599. TRAINING EVALUATION FORM MR/R/008 QCM
600. CPA LOG SHEET MR/R/009 QCM
601. CPA REQUEST FORM MR/R/010 QCM
602. CPA ACTION FORM MR/R/012 QCM
603. ACKNOWLEDGEMENT FORM MR/R/013 QCM
604. AUDIT NON CONFIRMANCE REPORT MR/R/014 QCM
605. OBJECTIVE AND TARGET FORM MR/R/015 QCM
606. OBJECTIVE AND MONITOTRING FORM MR/R/016 QCM
607. OBJECTIVE AND MONITOTRING FORM MR/R/017 QCM
608. AUDIT NON CONFIRMANCE REPORT MR/R/018 QCM
609. FLOW CHART FOR TRAINING MR/R/019 QCM
610. MINUTES OF MEETING MR/R/020 QCM
611. AUDIT PROGRAME MR/R/021 QCM
612. AUDIT PLAN MR/R/023 QCM
613. TRAINING RECORD FORM MR/R/024 QCM
614. ACCIDENT REPORT FORM MR/R/025 QCM
615. HOLD TIME STUDY REPORT SN/HTS/QR/007 QCM
616. PASS BOX VALIDATION REPORT MR/R/026 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
617. HOLD TIME STUDIES FOR MEDIA PREPARATION MR/R/027 QCM
REPORT
618. HOLD TIME STUDIES FOR GLASSWARES AND MR/R/028 QCM
ACCESSORIES REPORT
619. HOLD TIME STUDIES FOR GARMENTS REPORT MR/R/029 QCM
620. HOLD TIME STUDIES OF SWAB SAMPLE FOR MR/R/030 QCM
MICROBIOLOGY LAB
621. INVESTIGATING REPORT FOR MICRO FAILURES MR/R/031 QCM

SOP’s LIST (SOP FOR MICROBIOLOGY SECTION)(File # 06)

S.No DOCUMENTS NAME DOCUMENTS CODE AUTHOR

622.
LAL TEST (GEL CLOT TECHNIQUE) SN/QC/SOP/MIC/001 QCM
623.
MICROBIAL CONTAMINATION CONTROL SN/QC/SOP/MIC/002 QCM
624.
STERILITY TEST SN/QC/SOP/MIC/003 QCM
625.
MEDIA PREPARATION SN/QC/SOP/MIC/004 QCM
626.
PARTICLE COUNT SN/QC/SOP/MIC/005 QCM
627.
SOP FOR MEDIA FILL VALIDATION TEST SN/QC/SOP/MIC/006 QCM
628.
RO TESTING SN/QC/SOP/MIC/007 QCM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
629.
LAL TEST (CHROMOGENIC METHOD) SN/QC/SOP/MIC/008 QCM
630.
CLEANING OF MICRBIOLOGY LAB SN/QC/SOP/MIC/009 QCM
631.
ENTRY AND EXIT INTO MICROBIOLOGY LAB SN/QC/SOP/MIC/010 QCM
632.
DISPOSAL OF MICROBIOLOGICAL WASTE SN/QC/SOP/MIC/011 QCM
633. MICROBIOLOGICAL ENVIRONMENTAL
SN/QC/SOP/MIC/012 QCM
MONITORING OF STERILITY ROOM
634.
PROCEDURE OF SWAB TEST SN/QC/SOP/MIC/013 QCM
635. STERILIZATION CYCLE OF DIFFERENT
SN/QC/SOP/MIC/014 QCM
METERIALS
636.
TESTING STERILE WATER FOR INJECTION SN/QC/SOP/MIC/015 QCM
637.
SOP FOR AUTOCLAVE VALIDATION SN/QC/SOP/MIC/016 QCM
638. SOP FOR PERSONAL MONITORING OF STERILE
SN/QC/SOP/MIC/017 QCM
AREA
639. SOP FOR MICROBIAL LIMIT TEST OF RAW
SN/QC/SOP/MIC/018 QCM
MATERIAL AND FINISHED PRODUCT
640. SOP FOR PREPARATION AND BIOBURDEN
SN/QC/SOP/MIC/019 QCM
MONITORING OF IPA 70%
641. SOP FOR VALIDATION OF ASEPTIC GOWNING
SN/QC/SOP/MIC/020 QCM
PROCEDURE
642. STANDARD OPERATING PROCEDURE FOR SN/QC/SOP/MIC/021 QCM
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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
GROWTH PROMOTION TEST FOR CULTURE
MEDIA
643. VALIDATION OF PASS BOX USED IN
SN/QC/SOP/MIC/022 QCM
MICROBIOLOGY LAB
644. SOP FOR HOLD TIME STUDIES FOR MEDIA
SN/QC/SOP/MIC/023 QCM
PREPARATION
645. HOLD TIME STUDIES FOR GLASS WARES,
ACCESSORIES SN/QC/SOP/MIC/024 QCM

646. HOLD TIME STUDIES FOR GARMENTS

SN/QC/SOP/MIC/025 QCM
647. PREPARATION OF DISINFECTANT SOLUTIONS
SN/QC/SOP/MIC/026 QCM
648. HOLD TIME STUDIES OF SWAB SAMPLE FOR
MICROBIOLOGY LAB SN/QC/SOP/MIC/027 QCM

649. GOOD MANUFACTURING PRACTICES IN

SN/QC/SOP/MIC/028 QCM
MICROBIOLOGY LAB
650. SOP FOR PREVENTIVE MEASURES AND
SN/QC/SOP/MIC/029 QCM
CLEANING EVALUATION OF AUTOCLAVE
651. SOP FOR PREVENTIVE MEASURES AND
CLEANING EVALUATION OF HOT AND COOL SN/QC/SOP/MIC/030 QCM
INCUBATOR
652. SOP FOR PREVENTIVE MEASURES AND
SN/QC/SOP/MIC/031 QCM
CLEANING EVALUATION OF HOT OVEN
653. SOP FOR PREVENTIVE MEASURES AND
CLEANING EVALUATION OF CONDUCTIVITY SN/QC/SOP/MIC/032 QCM
METER

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
654. SOP FOR INVESTIGATION OF FAILURES OOS
AND OOT RESULT IN MICROBIOLOGY LAB SN/QC/SOP/MIC/033 QCM

655. SOP FOR DISINFECTION OF MICROBIOLOGICAL

SN/QC/SOP/MIC/034 QCM
STERILITY ROOM

RECORDS OF QUALITY CONTROL/QUYALITY ASSURANCE

S.NO DOCUMENT NAME DOCUMENT CODE AUTHOR
656. Sop’s Toll Products File # 01 QCM/QAM
657. Sop’s Of Unit Cartons(Toll) File # 02 QCM/QAM
658. Sop’s Of Physical Testing File # 07 QCM/QAM
659. Content Uniformity Records File # 15 QCM/QAM
660. Hold Time Studies Report File # 16 QCM/QAM
661. Swab Test Reports File # 17 QCM/QAM
662. Sop’s Of Training Form Record (QA) File # 20 QCM/QAM
663. Supplier Certificates ( Non-Active) File # 21 QCM/QAM
664. Supplier Certificates (Active) File # 22 QCM/QAM
665. Complaints File # 23 QCM/QAM
666. Audit Form 2009- 2011 File # 24 QCM/QAM
667. Product Registration Short Comings File # 25 QCM/QAM
668. Warranty File # 26 QCM/QAM
669. Calibration Certificates File # 27 QCM/QAM
670. Environmental Procedures/Records File # 28 QCM/QAM
671. Internal Thermal Mapping Record File # 29 QCM/QAM

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Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
672. Objectives And Targets File # 30 QCM/QAM
673. DOP Reports File # 31 QCM/QAM
674. HVAC Documentation File # 32 QCM/QAM
675. Circulation Records File # 33 QCM/QAM
676. Master List File File # 34 QCM/QAM
677. Training Records File # 35 QCM/QAM
678. Ministry Letters File # 36 QCM/QAM
679. Company Profile File # 37 QCM/QAM
680. MOH Letters File # 38 QCM/QAM
681. Quality System Manual File # 39 QCM/QAM
682. CPA Request Form File # 40 QCM/QAM
683. Minutes Of Meeting File # 41 QCM/QAM
684. Quality System Procedures File # 42 QCM/QAM
685. Customer Feedback Form File # 43 QCM/QAM
686. Management Review Meeting File # 44 QCM/QAM
687. Audit Reports File # 45 QCM/QAM
688. Audit Form File # 46 QCM/QAM
689. Emergency Plan File # 47 QCM/QAM
690. Medicine Gate Pass File # 48 QCM/QAM
691. Master Formulations File # 49 QCM/QAM
692. Self Inspection Record File # 50 QCM/QAM
693. Product List File # 51 QCM/QAM
694. Art Work Approvals File # 53 QCM/QAM
695. Instruments Calibration Records File # 54 QCM/QAM

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 10.August.2020
Shawan pharmaceuticals
Department Quality Control Issue # 0 2
Section Quality Control Issue Date 0 1 - 2 0 1 8
MASTER LIST
TOLL
PRODUCTS
01. VALIXIME 100MG/5ML SUSPENSION SN/QC/SAP/TOLL/V-001 QCM/QAM
Each 5mL Contains:-
Cefixime asTrihydrate ………..100mg.
(USP Specs)

02. SULGEN 1000MG INJECTION SN/QC/SAPP/TOLL/002 QCM

Each Vial Contains:-
Cefoperazone as Sodium…..500mg.
Sulbactum as Sodium…..…..500mg
(JP Specs)
03. SULGEN 2000MG INJECTION SN/QC/SAPP/TOLL/003 QCM
Each Vial Contains:-
Cefoperazone as Sodium…..1000mg.
Sulbactum as Sodium…..…..1000mg
(JP Specs)

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