SOP (Standard Operating Procedure) is a written document procedure involved in processes that are followed during the operation. They can be explained as “These are a series of documented guidelines that define step-by-step instructions for different procedures in drug manufacturing to assure consistency, quality, and safety”. They help in the maintenance of product quality, the prevention of errors, and compliance with regulatory authorities such as the USFDA, MHRA, and ICH Requirements.
This whole section of Pharma SOPs belongs to different departments like; Production, Quality assurance, Quality control, Maintenance, Microbilogy, Warehouse, Engineering, IT, and P&A.
Full List of Pharma SOPs
- SOP for Operating and Cleaning of Dry Bath Incubator
- SOP for Water Purifier
- SOP for Cleaning and Operation of Outside Micrometer
- SOP for Multi-Stem Thermometer with external sensing probe
- SOP for Cleaning and Operating of Digital Timer
- SOP for Disassembling, cleaning, and assembling Filter Housing
- SOP for cleaning, operation, and calibration of Muffle Furnace
- SOP on Good Documentation Practices
- Pharma Guideline on How to Prepare SOP (SOP of SOP) with Formats
- SOP on Transfer and Receipt of bulk (ARM) from Warehouse to Production area
- Procedure for Thawing of Solution and Active Raw Material
- Fluidized bed Dryer Bag SOP (FBD)
- SOP for estimation of Nickel (IS 12122 -1987)
- SOP for Estimation of Sodium (Part 45)
- SOP for estimation of BORON
- SOP on Reference Standards and impurities
- SOP on Working Standards- Preparation, Qualification, Usage, Storage, and Destruction
- SOP on Operation of Fume Hood
- SOP on Procurement, Usage, and Storage of Primary Standards
- SOP on intimation to QC Department for Retesting of Raw Materials
- SOP for Operation and Calibration of Flame Photometer
- SOP for Operation of Digital Griffin Flask Shaker
- SOP on Temperature Mapping in RM, PM, FG and Control Sample Area
- SOP on Preventive Maintenance of Auto Coater Machine
- SOP for Monitoring and Recording Critical Environmental Parameters of Different classes
- SOP for Estimation of Mercury using Atomic Absorption Spectroscopy
- SOP for Microbiological Testing of In-Process Packing Material (Bioburden Test)
- SOP for Operating and Validating Anaerobic Systems
- SOP for Operation and Cleaning of Domino Thermal Inkjet Printer
- SOP for Carton 2D Barcode Printing Machine
- SOP for Operation and Cleaning of Automatic Cartoning Machine (CP-150)
- SOP for Operating and Validating a Biosafety Cabinet
- SOP for Operating and Cleaning a Vortex Mixer in Microbiology
- SOP on Operation and Calibration of the Antibiotic Zone Reader
- SOP for Operation and Calibration of Heating Block
- SOP for Operation and Validation of Laminar Air Flow Hood
- SOP on Procedure for Operating a Centrifuge Machine
- SOP for Operation and Calibration of Colony Counter
- SOP on Recruitment of Employees by HR
- SOP for Preventive Maintenance of DM Plant
- SOP for Handling Chemicals used for Purified Water Plant
- SOP on Withdrawal, Storage, Observation & Destruction of Control Sample
- SOP on Receipt and Handling of Laboratory Samples
- SOP on Out of Acceptance Limit in Purified Water System
- SOP on Operation And Calibration Of Karl Fischer Apparatus
- SOP for Analysis and Release of Packing Materials
- SOP for HPLC Column Cleaning and their Maintenance
- SOP on Return of Excess Packing material
- SOP on Management of Sieves/ Screens / FBD bowl mesh
- SOP on Procedure for the cleaning of SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, new sieve / screen and accessories
- SOP on Procedure for Coding Accessories
- SOP on Operation of Tablet inspection belt
- SOP on Monoblock Filling and Sealing Machine
- SOP on Online inspection of Washed empty / filled/ labeled bottles
- SOP; Preparation and Approval of Bill of material (BOM)
- SOP on Cleaning of Shipper Sealing machine
- SOP for Shifts Handover between the Shifts
- SOP on Operation of Bin Blender
- SOP on Cleaning of Strip Pack Machine
- SOP for Index Type Rotary Bottle Washing Machine
- SOP for Operation & Calibration of pH Meter
- SOP for Operation and Calibration of Dissolution Apparatus (Tester)
- SOP for Operation and cleaning of Tunnel sterilizer
- SOP for Liquid tanks, Pipelines, and Filling machine
- SOP for Operation and Calibration of Analytical Balance
- SOP on Pest & Rodent Control
- SOP for Operation & Calibration of Water bath
- SOP for Cleaning and Storage of Filling accessories
- SOP on Receipt Materials Bill Realization and Deviation
- SOP for Operation and cleaning of lyophilizer
- Sterilization of Piping System of blending Tanks
- SOP for Manual Visual inspection of filled vials
- SOP for Operation of Particle counter
- SOP for Magnetic Stirrer in Pharmaceutical
- Calibration of HPLC and their Operation SOP
- SOP for Operation, Calibration of Electronic balance
- SOP for Cleaning and Operation of Basket filter assembly
- SOP for Glassware Cleaning in QC Lab
- Method Validation of Analytical Procedures | SOP AMV (ICH Q2 (R1))
- SOP for Retesting and Resampling of Raw materials
- SOP for Operation of a Stainless Steel Reactor
- SOP for Automatic Strapping (banding) machine
- SOP for Sanitization of the Storage tank and Distribution Loopline
- SOP for Operation and cleaning of mobile SIP unit
- SOP for Operation and cleaning of Tray loading machine
- SOP for Operation of Box Cutting and Vial loading
- SOP for Tub Handling of prefilled syringes of filling machine
- SOP for Cleaning and Operation of Vacuum scrubber
- SOP for Transfer of Semi packed material to warehouse
- SOP for Preparation of Rubber bungs
- SOP for Cleaning and Operation of conveyor belt and turn table
- SOP for the Cleaning, Operation of Labeling machine
- SOP for Procedure for Bottle Inspection
- SOP for Procedure for Calibration of Dipstick
- SOP on Sanitization of Drain Points
- SOP on Washing, sterilization of clean room Garments
- SOP on Cleaning, Preparation of filling machine accessories for sterilization
- SOP on Cleaning and Preparation and Packing of Material for Sterilization
- SOP on Aseptic Handling, Operation and Aseptic Connection
- SOP on Operation and Cleaning of Fluidized Bed Drier
- SOP on initiating, incorporating, approval and recording changes to the master documents
- SOP on Status Labeling in Pharmaceutical Department
- SOP on Cleaning and Operation of Blister Pack Machine
- Procedure for investigation of Out of Specification (OOS) and SOP Formats
- SOP on Making Entries in inward/outward Register
- Sop on Non-conforming Results in Total Microbial Count in Water Samples
- SOP for Storage and Preparation of Media and Culture
- SOP on Procedure for Hot Air Oven Operation & Calibration
- Procedure for the Usage, Control, and Storage of Change Parts for liquid orals
- SOP on Operation and Procedure of Pharmacode Reader
- SOP on Operation and Cleaning of the Decontamination Autoclave
- Annexure for Decontamination Autoclave
- SOP on Cleaning and Operating of ZEBRA Printer
- Procedure for Operation of 37 Stations Double Rotary Compression Machine
- Procedure for Issuance, Use, and Retrieval of Punches and Dies
- SOP on Procedure for Making Entries in Equipment Usage Log Book
- SOP on Operation of 35 Station Double Rotary Compression Machine.
- SOP on IR Moisture Balance, Operation, and Calibration
- Sop for Destruction of Rejected Dies and Punches
- SOP on Destruction of Rubber Stereos
- SOP on Indent and Approval of Rubber Stereo for Overprinting
- SOP on Cleaning of Coating Solution Preparation Tank
- SOP to Initiate, Incorporate, Approve and Record Changes to the Master Documents
- SOP on Transfer of Finished Products to Finished Goods Stores
- SOP on Indent, Inspection, and Maintenance of Punches and Dies
- SOP on Disintegration Test (DT Apparatus ) Cleaning, Operation, and Calibration
- SOP on Cleaning, Operation of the Automatic Dosing Cap Pressing Machine
- SOP on Disposal in Tablet Department
- SOP for Footwear Cleaning in Pharmaceutical
- SOP on operation and calibration of autoclave
- SOP On Movement of Material from One Stage to Another
- SOP on Operation of Filter Press
- SOP on Monitoring Temperature, Relative Humidity, and Differential Pressure
- SOP on Inventory and Storage of Sieves, Screens
- SOP on cleaning of new equipment/machinery
- SOP on Change Control / FDA Change Control
- SOP on Handling Products During a Power Failure
- SOP on Cleaning of Paste Preparation Kettle
- SOP on Cleaning and Operation of Printing and Rewinding Machine for Labels.
- SOP on Procedure for Non-Viable Particle Count (Locations, limits, and Frequency)
- SOP on the Procedure for Packing Vials
- SOP on Receiving and Transfer the FGTN to Warehouse
- SOP on Cleaning and Operation of Carton Coding Machine
- SOP on Decontamination of used Material Contacted with API
- SOP for handling Filled Bottles labeled with improper labels
- SOP on inspection unit for Empty and Filled Bottles
- SOP on Cleaning Utensils, SS Accessories, and Machine Change Parts
- SOP for Glass | Vial | Syringes Crushing Machine
- SOP on Microbiological Monitoring of Compressed Air
- SOP on Verification of Sugar Dissolving Tank, Manufacturing and Holding Tank
- SOP on Polishing of Punches and Dies
- SOP On Change of Aluminum Foil During Packing
- SOP for the Operation of Shipper Sealing Machine
- SOP on Design, Print, issuance, and Control of Logbooks
- SOP on cleaning of Conveyor belt
- SOP on Reconciliation & Destruction of Packing materials.
- SOP on Preparation of Aluminum Seals
- SOP on the Removal of Broken Down equipment
- SOP on the Procedure for Receiving, Handling, and storage of Primary and Secondary packaging Material
- SOP on Operation and cleaning of the Bung Processor
- SOP on Cleaning and Operation of Dynamic Pass Boxes
- SOP on Cleaning & Operation of Peristaltic Pump
- SOP on Repacking of Finished Product
- List of Standard Operating Procedure (SOPs) in OSD Production
- SOP on Fogging at the Production Floor and Service Floor
- SOP On Operation of Pouch Sealing machine
- SOP on Sanitizing Solution Preparation
- SOP on the Operation of Auto Coater
- SOP on Operation of Strip Pack machine
- SOP on Operation of Colloidal Mill
- SOP for Operation of Multimill in Pharmaceutical
- SOP on Checking Balance Eccentric Accuracy
- SOP on the Operation of Vacuum Cleaner
- SOP on Cleaning, Utilization FBD Finger Bag and Filter Bag
- SOP on Operation of Metal Detector
- SOP on Operation, Calibration of Friability Test Apparatus
- Procedure for Growth Promotion Test in Microbiology
- SOP on the Operation and cleaning Infrared Thermometer
- Procedure For Operation Of Refrigerator
- SOP on Cleaning and Operation of Polarimeter
- SOP Operating of Vials Labeling Machine
- SOP Operation and Cleaning BOD Incubator in Microbiology Department
- SOP on cleaning And Operation of Static Pass Box
- SOP on Cleaning Operation Tablet Hardness Tester
- SOP on Cleaning / Sanitization Microbiology Department
- Standard Operating Procedure for Door Interlock System
- SOP on Disposal of Microbial Media in Microbiology
- Sop on Cleaning and Monitoring Aseptic area
- SOP for Dry Heat Sterilization in injection section
- SOP on Handling Scrap and Disposal in Pharmaceutical
- SOP for Cleaning and Operation of vials washing machine
- SOP on Sterilized Powder filling machine
- Depyrogenation method and washing of Test tubes for BET
- Entry and Exit Procedure for staff, visitors in Pharmaceuticals
- SOP on Cleaning Procedure for Sterility Failure investigation
- SOP on Operation of Laminar airflow in a Micro laboratory
- Procedure for Microbial Incubator operation & Calibration
- Procedure for Planned Internal Quality Audits in Pharma
- SOP on Storage and Movement of unlubricated granules / Transfer
- SOP on Storage and labeling of Raw and Packing Materials
- SOP on Rapid Mixture Granulator cleaning and procedure
- SOP on Vibro Sifter operation and Cleaning
- SOP on Collection of Swab and Rinse Water Samples
- SOP for Cleaning of Quality control department
- isopropyl Alcohol 70 percentage Preparation SOP
- SOP on Tipper operation and cleaning
- In Process Quality check during Manufacturing
- SOP on Storage and Hold Time Study for Products
- Daily Verification of Weighing balance SOP
- Induction Cap Sealer machine SOP
- Entry exit Procedure in Pharma SOP
- Product Waste; Collection and Disposal
- SOP on Operation, cleaning of Leak Test Apparatus
- SOP for Camera Vision System and Pinhole detector
- SOP on Cleaning and Sanitization in Pharmaceutical
- SOP on the Training of Personnel in Pharmaceutical
- SOP on Solid flow Monitor Test in Fluid bed dryer
- SOP for Calibration of Weighing Balance (Trolley balance)
- SOP for Coding and Calibration of Standard Weight
- SOP for Acceptable Quality Level with Chart Parameters
Note: Pharmaceutical SOPs PDF will be included soon…If required you can Download SOPs PDF Directly from here.