MANUFACTURING SOP IN PHARMA (TABLETS/INJECTABLES/OINTMENTS/ORAL LIQUID/HARD GEL/SOFT GEL)

Manufacturing SOP in pharma, a component of the pharmaceutical business, is the process of synthesizing pharmaceutical medications on an industrial scale. A number of unit operations, including milling, granulation, coating, tablet pressing, and others, can be used to breakdown the drug production process into its component parts. The synthesis of the active ingredient or drug (primary processing, or manufacture) and the transformation of the active medications into products appropriate for administration are the two main steps of pharmaceutical manufacturing.

TABLETS

1. SOP for Charge Hand over between Shifts
2. SOP for Cleaning and challenge test of Solid Flow Monitor for Fluidized Bed Dryer
3. SOP for Handling of feeding area
4. SOP for Cleaning of Lifting and Positioning Device
5. SOP for Operation of Bin washing and Drying Machine (Cybernetik)
6. SOP for Operation of 45 stn Compression Mc (Cadpress D Tooling)
7. SOP for Operation and Cleaning of Vernier caliper
8. SOP for Operation of Bin washing and Drying Machine (Cybernetik)
9. SOP for Operation and Cleaning of Nimach Code Printer Machine (NIMACH)
10. SOP for Operation and Cleaning of NFD for strip pack machine
11. SOP for Operation and Cleaning of Leak test apparatus
12. SOP for Operation and Cleaning of Hand coder
13. SOP for Operation and Cleaning of Bin Blender 1200 litre (SAAN)
14. SOP for Operation and Cleaning of Automatic Cartoning Machine (HI-CART)
15. SOP for Operation and Cleaning of Packing Conveyor Belt
16. SOP for Operation and calibration of Moisture Analyzer (Sartorius)
17. SOP for Operation & Cleaning of Colloidal Mill
18. SOP for Movement of material from one Stage to another
19. SOP for Monitoring of Temperature, Relative Humidity and Differential Pressure
20. SOP for Making entries in inward Outward register in production
21. SOP for Issuance of consumable item to Production from store
22. SOP for In process checks during batch manufacturing and Packing
23. SOP for Cleaning, Operation and calibration of Disintegration test apparatus (Electrolab)
24. SOP for Entry and Exit procedure of male and female staff workers in Production area
25. SOP for Cleaning, Operation & Calibration of Analytical Weighing Balance
26. SOP for Cleaning of Vibro sifter 30” (Bectochem)
27. SOP for Cleaning of Utensils
28. SOP for Cleaning of Rapid Mixer Granulator 150 litre (Bectochem)
29. SOP for Cleaning of Paste kettle 100 liter. (Make Bectochem)
30. SOP for Cleaning of Octagonal Blender
31. SOP for Cleaning of Multimill (Bectochem)
32. SOP for Cleaning of Fluidized Bed Dryer 60 Kg (Bectochem)
33. SOP for Cleaning of FBD Co-Mill 5 HP
34. SOP for Cleaning of Co-Mill 10 HP
35. SOP for Cleaning of Combo Metal Detector cum Deduster
36. SOP for Cleaning of Blister packing machine (EPI 3010)
37. SOP for Cleaning of Bin washing and Drying Machine (Cybernetik)
38. SOP for Cleaning of Autocoater 60” (Bectochem)
39. SOP for Cleaning of 45 stn Compression Mc (Cadpress D Tooling)
40. SOP for Cleaning and Sanitization of Production Area
41. SOP for Cleaning and Operation of Pinhole Detection System
42. SOP for Cleaning and Operation of De-Blistering machine
43. SOP for Cleaning, Operation and Calibration of Friabilator (Electrolab EF2)
44. Operation of Vibro sifter 48”(Bectochem)
45. Operation of VTS Bectochem
46. Operation, Calibration and Cleaning of Tablet Tester
47. Procedure for Area line clearance
48. Procedure for indent, receipt issue, usage and destruction of rubber stereos
49. Procedure for Inventory, cleaning and storage of FBD finger bag RMG filter ba
50. Procedure for issuance of additional Raw and Packing material from Store
51. Procedure for numbering system of miscellaneous items
52. Procedure for on line rejection of Raw material and Packing material
53. Procedure for Opening and Closing of Production Area
54. Procedure for Packing operation
55. Procedure for polishing of Dies and Punches
56. Procedure for procurement, inspection, utilization and destruction of dies and punches
57. Procedure for procurement, receipt and handling of packing change parts
58. Procedure for Receipt and Verification of Raw material and Packing material in Production from Store
59. Procedure of filling of equipment log book
60. Process for waste disposal
61. Reconciliation and destruction of leftover coded packing materials
62. Return of unused leftover packing materials to Store
63. Sanitization of Drain points
64. Selection criteria for type of cleaning in production area
65. Status Labeling in Production Dept.
66. Transferring finished goods from packing department to FG store
67. Operation of Vibro sifter 30” (Bectochem)
68. Operation of Rapid Mixer Granulator 1200 liter (Make Bectochem)
69. Operation of Rapid Mixer Granulator 600 litre (Bectochem)
70. Cleaning of 55 stn Compression Mc (Cadpress D Tooling)
71. Cleaning of 75 stn Compression Mc (Cadpress BB Tooling)
72. Cleaning and Operation of Blister Packing Machine (BQS)
73. Procedure for operation of Rapid Mixer Granulator 150 litre
74. SOP for Cleaning of Coating Pan
75. SOP for Cleaning of Compression Machine
76. SOP for Checking the Sieve integrity
77. SOP for Cleaning of Autocoater
78. SOP for Cleaning of Carton Coding Machine
79. SOP for Cleaning of Conveyor Belt
80. SOP for Cleaning of Dust Extractor
81. SOP for Cleaning of FBD (Solace)
82. SOP for Cleaning of FBD Groovers
83. SOP for Cleaning of Homogeniser
84. SOP for Cleaning of Inspection Belt
85. SOP for Cleaning of Leak Test Appratus
86. SOP for Cleaning of Multi Mill
87. SOP for Cleaning of Pharma Pack Blister Machine
88. SOP for Cleaning of Tablet Dedustor
89. SOP for Operation of Tablet Deduster
90. SOP for Operating and Cleaning of Stirrer
91. SOP for Receipt of the material and GRN preparation
92. SOP for Pest Control
93. SOP for Personal training
94. SOP for Personal Hygiene
95. SOP for Raw Material Stored in Quarantine
96. SOP for Maintaining of Dispensing area
97. SOP for Issuance and Receiving of Punch Set
98. SOP for Internal labelling
99. SOP for Inspection of Punch and Dies
100. SOP for House Keeping of the Factory Premises
101. SOP for Gowning
102. SOP for Cleaning of RMG
103. SOP for Cleaning of Sifter
104. SOP for Cleaning of SS Equipment
105. SOP for Cleaning of Steam Pan
106. SOP for Cleaning of Stirrer
107. SOP for Cleaning of Strip Pack Machine
108. SOP for Dedusting of the Raw and packing Material at the time of Receipt
109. SOP for Cleaning of Defoiling machine
110. SOP for Dispensing of the Raw Material
111. SOP for Effluent Treatment Plant
112. SOP for Entry and Exit of personnel to the manufacturing area
113. SOP for Handling Rejected good
114. SOP for Operation of Compression Machine
115. SOP for Air curtain
116. SOP for Operation of Diesel Generator
117. SOP for Calibration of Checkweigher
118. SOP for Operation of Peristaltic Pump
119. SOP for Operation of Sifter
120. SOP for Operation of Steam Pan
121. SOP for Operation of Strip Pack machine
122. SOP for Particulate matter count monitoring
123. SOP for Checking of Sieve Integrity
124. SOP for Cleaning of AC unit
125. SOP for Cleaning of Dehumidifier
126. SOP for Cleaning of Over head tank
127. SOP for General Cleaning
128. SOP for Insectocutor
129. SOP for Issuance and Receiving of Punch set
130. SOP for Receipt of the Raw and Packing Material
131. SOP for Operation of Leak Test Apparatus
132. SOP for Operation of Boiler
133. SOP for Operation of AC unit
134. SOP for Operation of Multimill
135. SOP for Operation of Dust extractor
136. SOP for Operation of Defoiling machine
137. SOP for Operation of Conveyor Belt
138. SOP for Operation of Compression Machine
139. SOP for Operation of Carton Coding machine
140. SOP for Operation of Autocoater
141. SOP for Transfer of Dispensed material to Day Store
142. SOP for Operation of Rotovac 210S blister pack machine
143. SOP for Operation of RMG
144. SOP for Regeneration of Soft water plant
145. SOP for Regeneration of Demineralised water plant
146. SOP for Operation of Soft Water Plant
147. SOP for Cleaning And Operation of Checkweigher cum Metal Detector
148. SOP for Cleaning and Operation of High Pressure Jet Cleaner
149. SOP for Checkweigher cum Metal Detector
150. SOP for Checking of Sieve Integrity
151. SOP for Checking of Final Volume in Liquid Orals
152. SOP for Charge Handover between the Shifts
153. SOP for Change of Aluminium Foil during packing
154. SOP for Cleaning and Operation of Scrubber Machine (Roots Hakomatic E 430)
155. SOP for Calibration of Checkweigher
156. SOP for Cleaning and Operation of Induction Cap Sealer (Electronic devices)
157. SOP for Cleaning and Operation of Tablet loader Machine
158. SOP for Cleaning and Operation of Blister Pack Machine (Rotovac-210V) with Jekson Camera System
159. SOP for Destruction of rejected Dies and Punches
160. SOP for Cleaning and Operation of Carton Packing Machine (CP-120)
161. SOP for Charge hand over between the shifts
162. SOP for Change of Aluminum Foil during packing
163. SOP for Carton over printing machine with Pharma Code
164. SOP for Cleaning and Operation of Sachet Desiccant Inserter
165. SOP for Cleaning and Operation of Air Jet Micronizer
166. SOP for Cleaning and operation of barcode printer to create the barcode labels, selection of GTIN for different packing levels and procedure for coding and labeling of secondary and tertiary packaging material
167. SOP for Verification of Assay and LOD for API
168. SOP for Air Jet Cleaning Unscrambler
169. SOP for Cleaning, Calibration and Operation of Weighing Balances (ESSAE 3000 gm)
170. SOP for Cleaning, Calibration and Operation of Weighing Balances (ESSAE 6000 gm)
171. SOP for Calibration of Checkweigher (Make Technofour)
172. SOP for Cleaning & Operation of Carton Overprinting machine with Pharmacode Reader (Make Jekson)
173. SOP for Change of aluminum foil during packing
174. SOP for Sieve Integrity
175. SOP for Change Hand Over between the Shifts
176. SOP for Checkweigher cum Metal Detector
177. SOP for Procedure for Cleaning and Operation of Track N Trace System
178. SOP for Cleaning and Operation of Air Jet Cleaning
179. SOP for Cleaning and Operation of Blister Pack Inspection System
180. SOP for Cleaning & Operation of Checkweigher cum Metal detector
181. SOP for Cleaning and Operation of Coating Solution Preparation Tank
182. SOP for Cleaning & Operation of Fogger Machine
183. SOP for Cleaning and Operation of Hot melt Gum dispensor
184. SOP for Cleaning and Operation of Packi 2 Camera Inspection System for Leaflet and Spoon Detection
185. SOP for Cleaning & Operation of Pot Sieve
186. SOP for Cleaning & Operation of Pressure Jet Cleaner Machine
187. SOP for Cleaning and Operation of Alu-Alu Blister Pack Machine
188. SOP for Cleaning and Operation Of Blister Packing Machine (BQS)
189. SOP of New Bulk Counter and Camera Inspection System
190. SOP for Cleaning ,Operation and Calibration of Tablet Hardness Tester
191. SOP for Cleaning and Operation of Air Jet Cleaner (Make cvc Model 1267)
192. SOP for Cleaning and Operation of Lift
193. SOP for Verification of Assay and LOD for API
194. SOP for Cleaning and Operation of RMG 100 L
195. SOP for Cleaning ,Operation and Calibration of Breaking force tester(Electrolab)
196. SOP for Procedure for Printout Verification of PLC, HMI, IPC System according to BMR
197. SOP for Storage of Materials in Day Stores and Quarantine Areas
198. SOP for Polishing of Punches and Dies
199. SOP for Issuance of Consumable Item through Requisition cum Issue Slip
200. SOP for Sanitization of Drain Point

INJECTABLES

1. SOP for Cleaning of Feet Cleaning Pad and Sticky Mat
2. SOP for Operation and Cleaning of Autoclave Cum Bung Processor
3. SOP for Disinfection of Seals
4. SOP for Handling of Filled & Sealed batch in Secondary Packing Area
5. SOP for Operation & Calibration of LPC
6. SOP for Operation and Cleaning of Ampoule Filling and Sealing Machine
7. SOP for Handling of Sterile area Garments
8. SOP for Operation and Cleaning of Sterilizing and Depyrogenating Tunnel
9. SOP for Operation and Cleaning of Sticker Labeling Machine
10. SOP for Procedure to calculate lower and upper limit of shipper weight
11. SOP for Receipt of batch from Production to Packing Department
12. SOP for Transfer and Receipt of Dispensed Raw and Packaging Material from Store
13. SOP for Operation, Cleaning, Calibration and Verification of Checkweigher
14. SOP for Batch Manufacturing
15. SOP for CIP of Production Equipments
16. SOP for Cleaning & Handling of Silicon Tubes
17. SOP for Cleaning & Sanitization of Drain Traps
18. SOP for Cleaning and Sanitation of Aseptic Manufacturing and Washing area
19. SOP for Cleaning and Filling of Isopropyl Alcohol Bottles
20. SOP for Cleaning and Sanitization of Machine parts and Accessories
21. SOP for Cleaning and Sterilization of Goggles
22. SOP for Cleaning of Bins and HDPE Container
23. SOP for Cleaning of Cartridge Filter
24. SOP for Cleaning of Garment Washing Machine
25. SOP for Cleaning of infeed turntable of Visual Inspection Machine
26. SOP for Cleaning of machine turntable
27. SOP for Cleaning of Pallets, Crates, Racks and Trolleys in Production Area.
28. SOP for De-bagging of Three Piece Vials
29. SOP for Decartoning of Ampoules
30. SOP for Decartoning of Vials
31. SOP for Operation and Cleaning of Vial Sterilizing and Depyrogenating Tunnel – (DPI)
32. SOP for Operation Cleaning of Filling Dropper Fixing Screw Capping Machine
33. SOP for Operation and Cleaning of Blister Packing Machine
34. SOP for Operation and Cleaning of Packing Conveyor
35. SOP for Operation and Cleaning of Powder Filling and Stoppering Machine(DPI)
36. SOP for Operation and Cleaning of Rapid Cooling Steam Sterilizer
37. SOP for Operation and Cleaning of Sterile Garment Pass Box
38. SOP for Operation and Cleaning of Sticker Labeling Machine
39. SOP for Issuance and Receiving of Punch set
40. SOP of New Bulk Counter and Camera Inspection System
41. SOP for Ordering, Receipt, Storage, Issuance and Destruction of Stereos

ORAL LIQUID

1. SOP for Air jet cleaning Unscrumbler
2. SOP for Checking of final volume in tank
3. SOP for Operation and Cleaning of Liquid Manufacturing Tank 2000 Ltr.
4. SOP for Verification of Sugar Dissolving tank, Manufacturing tank and Holding tank
5. SOP for Management of Change parts for Oral liquid
6. SOP for Cleaning and Operation of 1000 ltrs. Manufacturing Vessel
7. SOP for On Line Inspection of Washed Empty Filled Labeled Bottles
8. SOP for Cleaning and Operation of Solution Holding Tank
9. SOP for Handling of Recoverable Rejection during Filling & Sealing of Bottles
10. SOP for Cleaning and Operation of Sugar Transfer System
11. Cleaning and Operation of Process Line in Liquid Orals
12. SOP for Cleaning and Operation of Manufacturing & Sugar Syrup Preparation Tank

OINTMENT

1. SOP for Cleaning Procedure of Manufacturing Plant
2. SOP for Operation and Cleaning of Autopack Shrink Wrapping Machine
3. SOP for Operation, verification and Calibration of Load cell
4. SOP for Procedure for Operation and Cleaning of Condot Printer
5. SOP for Procedure for Operation, Cleaning and Calibration of Check Weigher
6. SOP for Cleaning & Operation of Auto-Cartoning Machine
7. SOP for Management of Sieves
8. SOP for Operation and Cleaning of two Head Volumetric Filling Machine
9. SOP for Operation and Cleaning of Air Jet Cleaning Machine
10. SOP for Operation and Cleaning of Automatic Sticker Labeling Machine
11. SOP for Operation and Cleaning of Automatic Two Head Capping Machine
12. SOP for Operation and Cleaning of Domino Printer
13. SOP for Operation and Cleaning of Dusting Powder Filling Machine
14. SOP for Operation and Cleaning of Dynamic Pass Boxes
15. SOP for Operation and Cleaning of Induction Sealing Machine
16. SOP for Operation and Cleaning of Six Head Volumetric Filling Machine
17. SOP for Operation and Cleaning of Shrink Wrapping Machine
18. SOP for Operation and Cleaning of Hot Plate
19. SOP for Operation and Cleaning of Pass Box
20. SOP for Operation and Cleaning of Roto Cube Blender – 500 Liters
21. SOP for Operation and Cleaning of Stirrer
22. SOP for Procedure for De-Cartoning and Cleaning of Tube, Bottle and Jar
23. SOP for Packing Material Rejection Stage Wise During Packing
24. SOP for Preparation and Usage of Cleaning Solutions
25. SOP for Prevention of Contamination and Cross Contamination
26. SOP for Production Process and Control
27. SOP for Reconciliation of Packaging Material
28. SOP for Recording of Equipment Log
29. SOP for Calibration of Vessels
30. SOP for Cleaning & Operation of Semi Automatic Crimping Machine
31. SOP for Cleaning & Sanitization of Holding Vessels
32. SOP for Cleaning and Sanitization of High Density Polyethylene Drum
33. SOP for Cleaning and Sanitization of Transfer Pump, SS Tank, SS Pipe & Hose Pipe
34. SOP for Cleaning of Conveyor Belt
35. SOP for Cleaning of New Machinery Equipment
36. SOP for Cleaning of Pallets, Crates, Racks and Trolleys
37. SOP for Cleaning, Sanitization & Operation of Multi Mix Plant with Load Cell 250 Kg
38. SOP for Cleaning, Sanitization & Operation of Multi Mix Plant with Load Cell-75 Kg
39. SOP for Destruction of Printed Packaging Material
40. SOP for Fogging in Production Area By Using 20 Virosil (Hydrogen Peroxide-10, and Silver Nitrate 0.01) and Fogger
41. SOP for Handling of Flexible tubes Silicon gaskets
42. SOP for Handling of Rubber Stereos and Metallic Stereos
43. SOP for Inward and Outward of Raw Material Bulk in Ointment and Oral Liquid Core Area
44. SOP for Load Cell Verification and Calibration
45. SOP for Operating and Cleaning Procedure for Carton Coding Machine
46. SOP for Operation & Cleaning of Filter Press and Filter Pad Management
47. SOP for Operation and Calibration Verification of pH Meter
48. SOP for Procedure for Cleaning of Containers, Utensils and Sampling Rod
49. SOP for Procedure for Issuance, Cleaning, Replacement & Destruction of Vent & Air Filter
50. SOP for Procedure for Operation, Cleaning & Sanitization of CIP Tank
51. SOP for Remove Defective Equipment from Production Area
52. SOP for Return of Excess Packaging Material
53. SOP for Storage of Machine Change Parts
54. SOP for Transfer and Receipt of Dispensed Raw and Packing Material from Warehouse
55. SOP for Tubes Crimp Coding Printing System

SOFTGEL

1. Cleaning of Utensils and accessories
2. SOP for Cleaning of Filter Cloth
3. SOP for Cleaning of Tray Trollies
4. SOP for Coding of Accessory Items
5. SOP for Handling of Encapsulation Dies and Segment
6. SOP for Operation and Cleaning of Capsule Polishing Machine
7. SOP for Operation and Cleaning of Colloidal-Mill
8. SOP for Issuance Usage, Cleaning and Destruction of Nylon Cloth
9. SOP for De-Oiling of Dried Capsules
10. SOP for Cleaning of Medicament Vessel
11. SOP for Operation and Cleaning of Planetary Mixer
12. SOP for Operation and Cleaning of Homogenizer Mixer
13. SOP for Operation and Cleaning of Triple Roller Mill
14. SOP for Operation and Cleaning of Gelatin Mass Colour Mixer
15. SOP for Operation and Cleaning of Gelatin Mass Holding Tank
16. SOP for Operation and Cleaning of three stage Semi-Drier tumbler
17. SOP for Operation and Cleaning of Encapsulation Machine
18. SOP for Disposal of Rejected Soft Gelatin Capsules
19. SOP for Operation and Cleaning Procedure for Gelatin Melting Reactor
20. SOP for Inspection and Storage of Soft Gelatin Capsules
21. SOP for Operation and Cleaning of Medicament Mixing Unit
22. SOP for Operation and Cleaning of Gelatin Cooking Vessel
23. SOP for Operation and Cleaning of Encapsulation Machine
24. SOP for Operation and Cleaning of Degreasing Pan
25. SOP for Operation and Cleaning of Inline Homoginizer
26. SOP for In process checks during batch manufacturing and Packing
27. SOP for Fumigation of Production Area
28. SOP for Disposal of Waste generated in soft gelatin Production department
29. SOP for Monitoring of Temperature, Relative Humidity and Differential Pressure
30. SOP for Operation and Cleaning of Colloid Mill
31. SOP for Operation and Cleaning of Fluidizer Tumbler Dryer
32. SOP for Operation and Cleaning of Hot Plate
33. SOP for Operation and Cleaning of Ultrasonic Water Bath

HARDGEL

1. SOP for Issuance and Retrieval of Change Parts for Hard Gelatin Capsule Filling Machine
2. SOP for Operation and Cleaning of Automatic Capsule Filling Machine (AF-150 T) and its Accessories
3. SOP for Operation and Cleaning of Semiautomatic Capsule Filling Machine
4. SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-120) and its Accessories
5. SOP for Operation and Cleaning of Automatic Capsule Filling Machine (A-60) and its accessories
6. SOP for Operation and Cleaning of Roto Cube Mixer

THREE PIECE

1. SOP for Transfer of Dispensed Container of Cyclosporine from Dispensing Area to Manufacturing Area
2. SOP for Handling and Storage of Accessories and Tools Used In Cyclosporine Dispensing and Manufacturing Area
3. SOP for Operation and Cleaning of HPHV Autoclave
4. SOP for Procedure of Cleaning (CIP) and Sterilization (SIP) of Manufacturing and Holding Tank
5. SOP for Operation and Calibration of Cap Torque Tester
6. SOP for Decontamination of Scrap for Cyclosporine Products
7. SOP for Preparation and Consumption of 2.5% Sodium Hypochlorite Solution
8. SOP for Handling of Spillage of Cyclosporine Products
9. SOP for Operation, Cleaning, Calibration and Verification of Checkweigher

AMPOULE

1. SOP for Operation and Cleaning of Static Pass Box Dynamic Pass Box Dynamic Garment Storage Cabinet
2. SOP for Operation and Cleaning of Pouch Sealing Machine
3. SOP for Operation and Cleaning of Depyrogenating Tunnel
4. SOP for Operation and Cleaning of Vertical Rotary Ampoule Washing
5. SOP for Operation and Cleaning of Label Printing and Rewinding
6. SOP for Operation of Online Airborne Particle Counter
7. SOP for Cleaning Operation of Long Size Hand Gloves of Filling
8. SOP for Operation and Cleaning of Garment Washing Machine
9. SOP for Visual Inspector of Filled Ampoules
10. SOP for Visual Inspection of Parenteral Products
11. SOP for Operation Cleaning of CIP-SIP System
12. SOP for Fogging Operation in Clean Area
13. SOP for Decartoning of Ampoules
14. Sop for Operation Cleaning and Intervention of Ampoule
15. SOP for Operation and Cleaning of HPHV Autoclave

FILL FORM SEAL

1. SOP for Fogging in Different Locations at FFS Section
2. SOP for Operation of Form Fill and Seal Machine
3. SOP for Handling, Cleaning and Destruction of Silicon Tubes
4. SOP for Procedure for Operation and Cleaning of Online Visual Inspection (Empty and Filled Bottles) Conveyor Belt Inspection Table
5. SOP for Procedure for Operation, Cleaning & Sanitization of Holding Tank Vessel (Non-Jacketed)
6. SOP for Procedure for Decartoning of Bottles
7. SOP for Procedure for Cleaning and Sanitization of Transfer Pump
8. SOP for Sanitization of Detachable Purified Water Pipeline
9. SOP for Procedure for Tank Calibration
10. SOP for Procedure for Transfer and Receipt of Dispensed Raw and Packing Material from Warehouse to Oral Liquid Section
11. SOP for Leak Test of Filled and Sealed Respules in FFS Section
12. SOP for Procedure for Operation and Cleaning of Liquid
13. SOP for Handling of LDPE Granules in FFS Section
14. SOP for Procedure for Operation and Cleaning of Sticker Labeling
15. SOP for Decontamination and Destruction of Bacillus Clausii Solution in Form, Fill Seal Section
16. SOP for Procedure for Operation and Cleaning of SS Turn Table
17. SOP for Procedure for Operation and Cleaning of Dosing Cup Placing Machine
18. SOP for Procedure for Operation and Cleaning of Bottle Sealing Machine
19. SOP for Procedure for Operation and Cleaning of Rotary Bottle Washing Machine
20. SOP for Clean and Sterilization in Place of Form, Fill and Seal Machine
21. SOP for Operation and Cleaning of Vertical Autoclave in FFS Section
22. SOP for Entry and Exit Procedure for CIP-SIP and Washing Rooms
23. SOP for Entry and Exit Procedure for Manufacturing area

DRY POWDER INJECTION

1. SOP for Handling of Power Failure of Parenteral Blocks
2. SOP for Dispensed Material Inward and Outward Movement
3. SOP for Garment Washing Machine
4. SOP for Preparation, Printing, Checking and Application of Shipper Label
5. SOP for Biometric System
6. SOP for Procedure for Re-Packing
7. SOP for Cleaning and Sanitization of Slippers
8. SOP for Load Cell Verification and Calibration of Manufacturing Vessels
9. SOP for Operation and Cleaning of Hi-Cart
10. SOP for Filter Transfer from Production
11. SOP for Operation and Calibration of pH Meter
12. SOP for Procedure for Charging of Vials, Dropper and Cap into the Hopper
13. SOP for Spillage Handling
14. SOP for Filtration of Bulk Solution
15. SOP for Batch Manufacturing
16. SOP for Hand and Foot Sanitization Procedure
17. SOP for Handling and Usage of Silicon Tubes
18. SOP for Compounding Holding Filling Vessel
19. SOP for Good Aseptic Practices in Aseptic Processing Area, Monitoring and Recording of Aseptic Intervention During Aseptic Processing
20. SOP for Operation and Cleaning of Deprogenating tunnel
21. SOP for Operation and Cleaning of Double Cone Blender
22. SOP for Handling of Tubular and Moulded Vials
23. SOP for Cleaning of Utensils in Dry Powder Injection Section
24. SOP for Operation and Cleaning Procedure for Vial Sealing Machine
25. SOP for Operation and Cleaning of Carton Coding Machine
26. SOP for Determination of Monocarton, Carton Pack, Shrink Outer and Shipper Weight Range
27. SOP for Operation and Cleaning of Filling Dropper Fixing Screw Capping Machine
28. SOP for Cleaning and Sterilization of Filling Assembly
29. SOP for Procedure for Cleaning ,Sanitization , Sterilization and Uses of Tools Spanners Used In Aseptic Area
30. SOP for Operation of Leak Test Apparatus
31. SOP for Permissible Hold Time for Cleaned & Sterilized Components
32. SOP for Monitoring of Temperature, Relative Humidity & Differential Pressure in Aseptic Area and Controlled Area
33. SOP for Movement of Used Blender from Blending Area to Equipment Washing Area
34. SOP for Transfer of Sterile Raw Material & Environmental Monitoring Kit Container in Aseptic Area Through Dynamic Pass Box
35. SOP for Operation and Cleaning of Garment Washing Machine
36. SOP for Preparation, Filtration, Storage, Usage, Distribution, and Destruction of Disinfectant Solution
37. SOP for Cleaning of Pallets, Crates, Racks, Trays, and Trolleys
38. SOP for Handling of Items, Instruments, and Accessories dropped on Floor During Aseptic Operations
39. SOP for Issuance, Usage, Replacement, and Integrity Testing of Filters
40. SOP for Cleaning and Filling of Isopropyl Alcohol Bottles
41. SOP for Operation and Cleaning of Integrity Tester Machine
42. SOP for Cleaning and Sanitization of Goggle
43. SOP for Operating and Cleaning Procedure for Carton Coding Machine
44. SOP for Operation and Cleaning of Shrink Wrapping Machine
45. SOP for Operation and Cleaning of LAF
46. SOP for Operating and Cleaning of Automatic High-Speed Injectable Powder Filling and Stoppering Machine
47. SOP for Operation and Cleaning of Autoclave Cum Bung Processor
48. SOP for Operation and Cleaning of High-Speed Linear Vial Washing Machine
49. SOP for Receipt and Handling of Rubber Stereos
50. SOP for Operation and Cleaning of Fogger & Fogging Operation in Sterile and Non-Sterile Area
51. SOP for Transfer and Receipt of Dispensed Packaging Material from Store
52. SOP for De-labeling of Filled and Sealed Vials
53. SOP for Labeling of Equipments and Containers
54. SOP for Handling & Destruction of In-Process Rejections
55. SOP for Cleaning and Sanitization of Sterile, Vial Washing, Ampoule Washing Area, Ampoule Hold Room, Manufacturing Area, and Unit Preparation Area

LARGE VOLUME PARENTERAL

1. SOP for Storage of Filled Sealed Containers of Large Volume Parenteral Products
2. SOP for In-Process check during Large Volume Parenteral Filling & Sealing
3. SOP for External Cleaning and Operation of Blow Fill Seal Machine
4. SOP for Code Change and Handling of Code Digit of BFS-603 Machine
5. SOP for Cleaning and Sterilization of Filters
6. SOP for Operation and Cleaning of Shipper Taping Machine
7. SOP for Monitoring of Temperature, Relative Humidity & DP
8. SOP for Usage, Replacement and Integrity Testing of Filters
9. SOP for Cleaning of Pallets, Crates, Racks, Trays and Trolleys
10. SOP for Management of Sterile Garment
11. SOP for Operation and Cleaning of Dynamic Pass Box
12. SOP for Receipt and Handling of Rubber Stereos
13. SOP for Reconciliation of Batch
14. Removal of Scrap from Production & Packing Area
15. SOP for Batch Manufacturing at LVP Line
16. SOP for De-Labeling of Bottles
17. SOP for Transfer of Filled Sterilized Bottle from Unloading Area to Packing Area
18. Cleaning of Compounding & Holding Vessel along with Product Line, Filter Housing & Pump by Manual Method
19. SOP for Operation and Cleaning of Laminar Air Flow Unit
20. SOP for Load Cell Verification and Calibration of Manufacturing & Holding Vessels
21. SOP for Destruction and Disposal of Rejected Packaging Materials
22. SOP for Transfer of Materials Article from one Grade to Another Grade Area
23. SOP for Operation and Handling of Biometric System
24. SOP for Filtration of Bulk Solution
25. SOP for Batch Manufacturing Procedure
26. SOP for Operation and Cleaning of Hi Cart Plus Cartoning Machine
27. SOP for Precautions to be taken after Major Breakdown
28. SOP for Good Manufacturing Practices in Aseptic Processing Area
29. SOP for Cleaning and Sterilization in Place of Blow Fill and Seal Machine
30. SOP for Hold Time Period of Bulk Solution and Filled Bottles
31. SOP for Operation of Garment Washing Machine
32. SOP for Replacement of Hydrophobic Cartridge Filter
33. SOP for Replacement of Silicon Gaskets & TC Clamp Used In Product Line of Mixing Tank to Holding Tank & Holding Tank to BFS Machine
34. SOP for Operation and Calibration of pH Meter
35. SOP for Objective Functions and Responsibilities of Production
36. SOP for Leak Test of Filled and Sealed Bottles
37. SOP for Cleaning of Utensils
38. SOP for PLC Password
39. SOP for Procedure for Cleaning of Sliding door
40. SOP for Labelling of Equipments and Containers
41. SOP for Changing of Product Transfer Pump
42. SOP for Cleaning, Sanitization of Drain Traps
43. SOP for Operation and Cleaning of Integrity Tester Machine
44. SOP for Operation and Cleaning of Dynamic Sterile Garment Storage Cabinet
45. SOP for Visual Inspection of Filled and Sealed Low Density Polyethylene (LDPE) Bottles
46. SOP for Loading of Filled Sealed Bottles in Autoclave Trolley
47. SOP for Procedure for Transfer and Receipt of Dispensed Raw and Packing
48. SOP for Entry and Exit Procedure in CNC Grade-D area and Manufacturing