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List of All SOP's

List of All SOP’s

List of QC SOP’s

 

  1. SOP Title:- Entry Exit Procedure in Quality Control Department
  2. SOP Title:- Cleaning and Operation of Sampling Booth
  3. SOP Title:- Cleaning of Glassware’s used in Quality Control Laboratory
  4. SOP Title:-Sampling, Analysis and Release or Rejection of Raw Materials
  5. SOP Title: Good Laboratory Practices
  6. SOP Title: Entry Exit Procedure in Quality Control Department
  7. SOP Title: Sampling, Analysis and Release or Rejection of Raw Materials
  8. SOP Title: Sampling, Analysis and Release or Rejection of Packing Materials
  9. SOP Title: Sampling, Handling and Analysis of Stability Study Samples
  10. SOP Title: Destruction of Laboratory Waste
  11. SOP Title: Calibration of Instruments and Equipment’s
  12. SOP Title: Supervision of Work in Quality Control Department
  13. SOP Title: Cleaning of Glassware’s used in Quality Control Laboratory
  14. SOP Title: Sampling and Analysis of Water for Chemical Analysis
  15. SOP Title: Cleaning and Operation of Sampling Booth
  16. SOP Title: Preparation of Certificate of Analysis
  17. SOP Title: Preparation and Handling of Laboratory Reagents
  18. SOP Title: Working Standard Preparation
  19. SOP Title: Preparation and Standardisation of Volumetric Solutions
  20. SOP Title: Procurement and Handling of Reference Standards/Impurity Standards
  21. SOP Title: Handling and Storage of HPLC Columns
  22. SOP Title: Validation of Analysts in Quality Control Department
  23. SOP Title: Handling of Laboratory Chemicals
  24. SOP Title: Analysis of Samples at Outside Testing Laboratory
  25. SOP Title: Procurement and Handling of Primary Standards
  26. SOP Title: Poisonous Chemicals
  27. SOP Title: Preparation of Analytical Work Report
  28. SOP Title: Handling of Instruments/Equipments Breakdown
  29. SOP Title: Preventive Maintenance of Instruments/Equipment’s
  30. SOP Title: Rinse And Swab Sample Analysis
  31. Title: Calibration of Glassware’s
  32. SOP Title: Allotment of Job Responsibilities in Quality Control Department
  33. SOP Title: Retesting of Raw Materials and Packing Materials
  34. SOP Title: Analysis and Release of Semi Finished and Finished Products
  35. SOP Title:- Preparation of Specifications , Standard Testing Procedures and General Testing Procedures
  36. Title: Operation, Cleaning and Calibration of pH/Conductivity Meter
  37. SOP Title: Operation, Cleaning and Calibration of Precision Weighing Balance
  38. SOP Title: Operation, Cleaning and Calibration of Karl Fischer Apparatus
  39. SOP Title: Operation, Cleaning and Calibration of Bulk Density Apparatus
  40. SOP Title: Operation, Handling and Cleaning of Stability Chamber
  41. SOP Title: Analytical Method Validation, Analytical Method Verification and Method Transfer
  42. SOP Title: Analytical Data Review and Result Transcription
  43. SOP Title: Chromatographic Analysis, Trouble shooting and Documentation
  44. SOP Title: Operation, Cleaning and Calibration UV-Visible Spectrophotometer
  45. SOP Title: Operation, Cleaning and Calibration of Vacuum Pump
  46. SOP Title: Operation, Cleaning and Calibration of Water Bath
  47. SOP Title: Operation, Cleaning and Calibration of Magnetic Stirrer
  48. SOP Title: Operation, Cleaning and Calibration of TLC UV Cabinet
  49. SOP Title: Operation and Calibration of Stop Watch
  50. SOP Title: Rounding and Reporting of Test Results
  51. SOP Title: Operation, Cleaning and Calibration of Vacuum Oven
  52. SOP Title: Operation, Cleaning and Calibration of Refrigerator
  53. SOP Title: Operation, Cleaning and Calibration of Bursting Strength Apparatus
  54. SOP Title: Operation, Cleaning and Calibration of Muffle Furnace
  55. SOP Title: Management of Laboratory Instruments
  56. SOP Title: User Account Control System
  57. SOP Title: Operation, Cleaning and Calibration of Ultrasonic Cleaner
  58. SOP Title: Cleaning and Sanitation of Chemical Section
  59. SOP Title: Operation and Calibration of Vernier Calliper
  60. SOP Title: Operation and Calibration of Micrometer Screw Gauge
  61. SOP Title: Operation, Cleaning and Calibration of Centrifuge Apparatus
  62. SOP Title: Operation, Cleaning and Calibration of Hot Plate
  63. SOP Title: Operation, Cleaning and Calibration of Heating Mantle
  64. SOP Title: Operation, Cleaning and Calibration of KBr Press Apparatus
  65. SOP Title: Operation, Cleaning and Calibration of Fourier Transform Infrared Spectrophotometer
  66. SOP Title: Operation, Cleaning and Calibration of Disintegration Tester
  67. SOP Title: Operation, Cleaning and Calibration of Hot Air Oven
  68. SOP Title: Operation, Cleaning and Calibration of Tablet Friability Tester
  69. SOP Title: Operation, Cleaning and Calibration of Tablet Hardness Tester
  70. SOP Title: Operation and Maintenance of Emergency Eyewash and Safety Shower
  71. SOP Title: Operation, Cleaning and Calibration of Moisture Analyzer
  72. SOP Title: Operation, Cleaning and Calibration of Analytical weighing Balance
  73. SOP Title: Preparation and validation of Excel Calculation Sheet
  74. SOP Title: Operation, Cleaning and Calibration of Fume Hood
  75. SOP Title: Operation, Cleaning and Calibration of Automatic Refractometer
  76. SOP Title: Operation, Cleaning and Calibration of Automatic Polarimeter
  77. SOP Title: Operation, Cleaning and Calibration of Digital Viscometer
  78. SOP Title: Operation, Cleaning and Calibration of Melting Range Apparatus
  79. SOP Title-Calibration of Gas Chromatography
  80. SOP Title-Calibration of High Performance Liquid Chromatography (HPLC)
  81. SOP Title- Chromatographic Analysis and Documentation
  82. SOP Title: Cleaning of Walk-In Type Stability Chambers
  83. SOP Title-Dissolution Profile Comparison
  84. SOP Title-Handling of Analytical Samples
  85. SOP Title-Handling of Hazardous Chemicals
  86. SOP Title-Management of HPLC/GC Column
  87. SOP Title-Operation of Alarm System
  88. SOP Title-Operation of Centrifuge Apparatus
  89. SOP Title-Operation of Gas Chromatography (GC)
  90. SOP Title-Operation of Hot Plate
  91. SOP Title-Operation of High Performance Liquid Chromatography (HPLC)
  92. SOP Title-Operation of Pin Hole Tester
  93. SOP Title-Operation of Rotary Shaker
  94. SOP Title-Operation of Total Organic Carbon Analyzer (TOC)
  95. SOP Title-Operation of Ultrasonic Bath

List of QA SOP’s

  1. SOP Title: Preparation of Standard Operating Procedures
  2. SOP Title: Change Control Management
  3. SOP Title: Handling of Deviations
  4. SOP Title: Resource Management Process
  5. SOP Title: Training
  6. SOP Title: Routine Monitoring of Facilities and Utilities
  7. SOP Title: Environmental Health and Safety Procedure
  8. SOP Title: Good Documentation Practice
  9. SOP Title: Incident Reporting and Investigation
  10. SOP Title: Validation and Qualification
  11. SOP Title: Handling of Product Complaints
  12. SOP Title: Vendor Evaluation and Approval
  13. SOP Title: Batch coding system
  14. SOP Title: Emergency Power Failure
  15. SOP Title: Product Manufacturing Quality Plan
  16. SOP Title: Product Recall Procedure
  17. SOP Title: Equipment & Machinery Maintenance
  18. SOP Title: Equipment/Instrument Calibration
  19. SOP Title: Control of Artworks
  20. SOP Title: Receipt, Storage and Handling of Finished Products
  21. SOP Title: Temperature and Relative Humidity Mapping
  22. SOP Title: Product Recovery
  23. SOP Title: Product Reprocessing
  24. SOP Title: Sampling of In-process and Finished Products
  25. SOP Title: Release of finished products
  26. SOP Title: Procedure for Stability Study of Drug Products
  27. SOP Title: Control of Non-Conforming Products
  28. SOP Title: Corrective And Preventive Action
  29. SOP Title: Annual Product Review
  30. SOP Title: Internal Audit/Self Inspection
  31. SOP Title: Management Review Meeting
  32. SOP Title: Production and Material Planning
  33. SOP Title: Out Of Specification (OOS)
  34. SOP Title: Procedure for Issuance of BMR and BPR
  35. SOP Title: Line Clearance in Production Area
  36. SOP Title: Temperature and Relative Humidity Monitoring
  37. SOP Title: Fumigation Procedure
  38. Title: Entry Exit Procedure in Core Area
  39. SOP Title: Destruction of Residues and Line Rejects
  40. SOP Title: Archival of Documents and Records
  41. SOP Title: Pressure Differential Monitoring

 


List of Microbiology SOP’s

  1. SOP Title: Entry Exit Procedure in Microbiology Section
  2. SOP Title: Cleaning of Used Glassware in Microbiology Section
  3. SOP Title: Procedure for Media Preparation and Sterilisation for various Microbiological Testing
  4. SOP Title: Decontamination of Media, Cultures and Microbial Waste
  5. SOP Title: Sampling of Water for Microbiological Analysis
  6. SOP Title: Environmental Monitoring
  7. SOP Title: Procedure for Validation of Laminar Air Flow
  8. SOP Title: Validation of Laboratory Autoclave located in Microbiology Laboratory
  9. SOP Title: Maintenance of Various Cultures used in Microbiological Analysis
  10. SOP Title: Determination of Minimum Inhibitory Concentration of Disinfectant
  11. SOP Title: Validation of Disinfectant’s Effectiveness
  12. SOP Title: Procedure for Fumigation in Microbiology Section
  13. SOP Title: Area Cleaning and Sanitation of Microbiology-Section
  14. SOP Title: Receipt and Storage of Dehydrated Culture Media/Bases and Reagents used for Microbiological Analysis
  15. SOP Title: Serial Dilution Preparation of Microbial Cultures
  16. SOP Title: Identification and Purity Verification of Master Microbial Cultures
  17. SOP Title: Testing Growth Promotion, Inhibitory and Indicative Properties of Culture Media
  18. SOP Title: Procedure for Surface Swab Analysis for Microbial Limits
  19. SOP Title: Procedure for Efficiency test for UV Light
  20. SOP Title: Operation and Cleaning of Autoclave
  21. SOP Title: Procedure for Operation and Cleaning of Microscope
  22. SOP Title:-Operation, Cleaning and Calibration of Colony Counter
  23. SOP Title: Procedure for Operation, Cleaning and Calibration of Incubator
  24. SOP Title: Operation and Cleaning of Laminar Air Flow Bench
  25. SOP Title: Operation, Cleaning and Calibration of Refrigerator
  26. SOP Title: Operation, Cleaning and Calibration of B.O.D. Incubator
  27. SOP Title: Receiving, Storage and Qualification of Biological Indicator
  28. SOP Title: Procedure to Determine Shelf Life of Reconstituted Media
  29. SOP Title-Bio-Load Analysis of Compressed Air
  30. SOP Title-Operation and Cleaning of Micropipette
  31. SOP Title-Operation and Cleaning of Microscope
  32. SOP Title-Operation and Cleaning of Pass Box
  33. SOP Title-Procedure for Fumigation in Microbiology
  34. SOP Title-Operation and Cleaning of Antibiotic Zone Reader

List of Calibration SOP’s

  1. Calibration of Analytical Balance-Daily
  2. Calibration of Analytical Balance-Monthly
  3. Calibration of HPLC
  4. Calibration of Volumetric Glasswares
  5. Calibration of Auto Titrator
  6. Calibration of Dissolution Apparatus- Chemical (PVT)
  7. Calibration of Dissolution Apparatus- Physical
  8. Calibration of Colony Counter
  9. Calibration of Drying Oven
  10. Calibration of Disintegration Apparatus (DT)
  11. Calibration of Friability Apparatus
  12. Calibration of FTIR Spectroscope
  13. Calibration of Gas Chromatography (GC)
  14. Calibration of IR Moisture Analyzer
  15. Calibration of Karl Fischer Titrator (KF)
  16. Calibration of Melting Point Apparatus
  17. Calibration of Drying Oven
  18. Calibration of Tap Density Apparatus
  19. Calibration of Total Organic Carbon Analyzer (TOC)
  20. Calibration of UV Cabinet
  21. Calibration of UV-Visible Spectrophotometer
  22. Calibration of Vacuum Oven
  23. Calibration of Viscometer
  24. Calibration of Weight Box
  25. Calibration of Antibiotic Zone Reader

List of Production SOP’s

  1. SOP Title: Operation, and Calibration of Metal Detector
  2. SOP Title: In-Process Quality Control of Tablets/Capsules
  3. SOP Title: Manual Inspection of Tablets and Capsules
  4. SOP Title: Operation and Calibration of Rapid Mixer Granulator (RMG)
  5. SOP Title: Operation and Cleaning of Stainless Steel Trolley
  6. SOP Title: Start Up of Production Activity After Long Period
  7. SOP Title: Operation and Calibration of Compression Machine
  8. SOP Title: Operation and Cleaning of Spraying Gun
  9. SOP Title: Operation and Cleaning of Multimill
  10. SOP Title: Operation and Calibration of Roto Cube Blender
  11. SOP Title: Operation and Cleaning of Tablet and Capsule Hand Counter
  12. SOP Title: Operation and Cleaning of Leak Test Apparatus
  13. SOP Title: Operation and Cleaning of Tablet Inspection Belt
  14. SOP Title: Inspection, Utilization and Cleaning of Punches and Dies
  15. SOP Title: Operation, and Cleaning of Strapping Machine
  16. SOP Title: Operation, And Calibration Of Blister Packing Machine
  17. SOP Title: Operation and Calibration of Weighing Balance
  18. SOP Title: Operation and Calibration of Strip Packing Machine
  19. SOP Title: Operation, and Cleaning of Vacuum Cleaner
  20. SOP Title: Operation and Cleaning of Tablet De-dusting Machine
  21. SOP Title: Operation and Cleaning of Vibratory Sifter
  22. SOP Title: Operation And Cleaning Of Colloidal Mill
  23. SOP Title: Operation and Calibration of Fluid Bed Dryer
  24. SOP Title: Operation and Calibration of Coating Pan
  25. SOP Title: Inward, Handling and Cleaning of FBD Finger Bag
  26. SOP Title: Operation and Cleaning of Dust Extractor
  27. SOP Title: Cleaning and Sanitation in Production Area
  28. SOP Title: Operation and Cleaning Calibration of Tray Dryer
  29. SOP Title: Operation and Cleaning of Stirrer
  30. SOP Title: Operation and Calibration of Digital Vernier Calliper
  31. SOP Title: Operation And Cleaning of Polishing Machine for Capsules
  32. SOP Title: Operation and Calibration of Double Cone Blender
  33. Title: Operation and Calibration of Capsule Filling Machine
  34. SOP Title: Operation and Cleaning of Empty Capsule Sorter
  35. SOP Title: Coding, Utilisation and Cleaning of Accessories

List of Engineering SOP’s

  1. SOP Title: Cleaning of 3 Micron Pocket Type Filters
  2. SOP Title: Cleaning of AHU/HVAC Micron Filters
  3. Title: Operation of Air Compressor
  4. Title: Operation of Boiler
  5. SOP Title: Operation of Diesel Generator Set
  6. SOP Title: Maintenance of Breakdown Equipment
  7. SOP Title: Regeneration of Water Softener
  8. SOP Title: Chlorination of Raw Water by Sodium Hypochlorite
  9. SOP Title: Preventive Maintenance of Factory & Buildings
  10. SOP Title: Cleaning of Underground Water Sump
  11. SOP Title: Cleaning of Over Head Raw Water Tank
  12. SOP Title: Cleaning of RO Water Tank
  13. SOP Title: Calibration of Magnehelic Gauge
  14. SOP Title: Cleaning of Reverse Osmosis Membrane
  15. SOP Title: Cleaning of Pre-Filter of MLT Laminar Air Flow Unit
  16. SOP Title: Preventive Maintenance of Equipment
  17. SOP Title: Sanitization of PW Storage and Distribution System
  18. Title: Operation and Preventive Maintenance of Reverse Osmosis (RO) & (EDI) System
  19. SOP Title: Operation of Reciprocating Liquid Chiller Plant
  20. SOP Title: Operation of De-Humidifier
  21. SOP Title: Heating, Ventilation and Air Conditioning System (HVAC)
  22. SOP Title: Operation of Air Conditioning Plant

 


List of HR SOP’s

  1. SOP Title: Administration/HR Procedure
  2. SOP Title: Pests Control
  3. SOP Title: Clothing, Hygiene and Entry of Personnel
  4. SOP Title: Laundering of Garments
  5. SOP Title: Medical Examination of Personnel
  6. Title: Cleaning of General Areas in the Premise
  7. SOP Title: Waste Management
  8. SOP Title: Plant Security Procedure

 


List of Warehouse SOP’s

  1. SOP Title: Management of Warehouse 
  2. SOP Title: Dispensing of Packing Materials
  3. SOP Title: Dispensing Of Raw Materials
  4. SOP Title: Receipt of Raw Materials and Packing Materials

 

 


List of Training Modules PPT

  1. Stability Studies – an overview
  2. TOPIC:- TRAINING TO THE EMPLOYEES
  3. TOPIC- DISSOLUTION
  4. TOPIC:- GOOD DOCUMENTATION PRACTICES
  5. Topic:- Change Control, Deviation & Incident Management
  6. Topic:- Stability Studies (1)- an Introduction
  7. Topic:-Stability Studies (2) – an overview
  8. Topic- Method Validation
  9. Topic:-Method Transfer
  10. Topic:- Process Validation

 


 

List of Limit Test

  1. Limit Test for Aluminium
  2. Limit Test for Arsenic
  3. Limit Test for Chloride
  4. Limit Test for Heavy Metals 
  5. Limit Test for Sulphates
  6. Limit Test for Potassium
  7. Limit Test for Iron
  8. Limit Test for Lead
  9. Limit Test for Clarity of solution
  10. Limit Test for Colour of solution
  11. General Identification Reactions of Ions and Functional Groups
  12. Determination of sulphated Ash
  13. Determination of Sulphur Dioxide
  14. Determination of Acetyl Value
  15. Determination of Saponification Value
  16. Determination Acid Value and Ester Value
  17. Determination of Hydroxyl Value
  18. Determination of Iodine value
  19. Determination of Peroxide Value
  20. Limit Test for Selenium
  21. Determination of Residue on Ignition
  22. Determination of Melting Range or Temperature
  23. Determination of Jelly Strength
  24. Determination of pH
  25. Determination of Freezing Point
  26. Determination of Viscosity
  27. Determination of Conductivity
  28. Determination of Weight Per Millilitre and Relative Density (Specific Gravity)
  29. Determination of Optical Rotation and Specific Optical Rotation
  30. Determination of Refractive Index
  31. Determination of Boiling Range or Temperature and Distillation Range  
  32. Determination of Powder Fineness
  33. Determination of Water by KF
  34. Determination of Loss on Drying (LOD)
  35. Determination of Bulk Density and Tapped Density of Powder
  36. Volumetric Solutions

 


 

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