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NanoSizer Liposome Extruders
Liposomes, LNP, & Nanoparticles
Nanoparticle Reagents
Quality Documentations (cGMP)
Filtration
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Quality and Manufacturing Documentations, Protocols and SOP
Documents for Quality System
Document
Quality Manual
Calibration Master Plan
SIte Master File - SMF
Cleaning Validation Master Plan
Computer System Validation Master Plan
Process Validation Master Plan
Validation Master Plan
$950.00
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$950.00
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Quality Control - Standard Operating Procedure
Standrad Operating Procedures
Dynamic Light Scattering (DLS)
UV-Vis Spectroscopy
Visual Inspection and Analysis
Chromatographic Assay by HPLC
Good Chromatography Practices
Calibration Program
Behavior in Quality Control
Reduced Testing
Quality Control Operation
Cleaning of Laboratory Glassware
Cleaning of Sampling Accessories
Control Samples of Finished Goods and Raw Materials
Data Backup in Quality Control
Metal and Glass Policy
Disposal of Analyzed Samples and Expired Control Samples
Disposal of Laboratory Waste
Sampling and Testing of Stability Samples
Good Laboratory Practices
Gowning Procedure for Quality Control
Gowning Procedure for Visitors in Quality Control
Handling of a Laboratory Incident
Handling of Out of Order Instruments
Regeneration of Silica Gel
Handling the Spillages in the Laboratory
Maintenance of Primary Standard
Preparation of Reagents and Volumetric Solutions
Re-analysis of Raw Material
Rounding off Analytical Results
Sampling and Testing of Purified and Potable Water
$950.00
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$950.00
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Quality Assurance
Standrad Operating Procedures
Technology Transfer
Site Master File
Change Control
Authorized Signatories
Corrective and Preventive Action (CAPA)
Handling of Incidence
Job Description
Document Issuance and Control
SOP
Data Integrity
Training
Deviation Control
Computer System Validation
Abbreviations used in Documentation
Process Validation
Analyst Validation
Analytical Method Validation
Cleaning Validation
Disposal of Waste
Document Numbering System
External Lab Audit
Good Documentation Practices
Handling of Market Complaints
IPQA
Line Clearance of Equipment
Metal and Glass Policy
Out of Calibration
Out of Expectation Results
Preparation of Annual Product Quality Review
Preparation of MFR, BMR and BPR
Preparation of Validation Master Plan
Prevention of Mix-up and Cross Contamination
Product Recall
Quality Risk Management
Reprocessing and Reworking Policy
Review of BMR
Rounding off Analytical Results for Reporting for Good Documentation Practices
Self Inspection
Stability Studies
Validation Documentation
Vendor Approval
$950.00
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$950.00
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Manufacturing Site - Standard Operating Procedures (SOPs)
Document
Storage of Temperature Sensitive Raw Materials
First Expiry First Out (FEFO) System
Handling of Rejected Packing Material
Issuance of Packing Material
Control of Cross-contamination and Mix-up
Handling of Rejected Raw Material
Opening and Closing of Warehouse
Handling of Spillage/ Breakage of Materials
Housekeeping in Stores
Cleaning of Dispensing Room
Plastic Pallets Cleaning
Temperature Mapping in Store
Cleaning of Dedicated Dispensing Pump & Pipe for Solvent
Cleaning of Dispensing Utensils
Dispatch of Finished Goods
Dispensing and Issuance of Raw Material
Disposal of Expired Finished Goods
Vehicle Inspection
Handling and Storage of RM and PM
Monitoring of Temperature and Relative Humidity
Receipt of Raw and Packing Material
Receipt/Issuance/ Storage and Handling of Solvent
Reconciliation of Raw & Packing Materials
Retesting of Raw Materials
Return of Raw and Packing Material from Production Department
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$950.00
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Calibration SOPs
Standrad Operating Procedures
Calibration of Dynamic Light Scattering
Calibration of HPLC
Calibration of UV-Vis Spectrophotometer
Calibration of Gas Chromatography (GC)
Calibration of Dissolution Apparatus
Calibration of Analytical Balance
Calibration of FTIR Spectrophotometer
Calibration of pH Meter
Calibration of UV-Cabinet
Calibration of Thermometer
Calibration of Oven
Calibration of Disintegration Test Apparatus
Calibration of Volumetric Glassware
Calibration of Bulk Density Tester
Calibration of Melting Point Apparatus
Calibration of Vernier Caliper
Calibration of Refractometer
Calibration of Sieve Shaker
Calibration of Conductivity Meter
Calibration of Karl Fischer Apparatus
Calibration of Muffle Furnace
Calibration of Refrigerator
Calibration of Friability Apparatus
Calibration of Bursting Strength Tester
Calibration of Viscometer
Calibration of Polarimeter
$950.00
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$950.00
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Production - Small Volume Parenteral (SVP)
Document
Dynamic Light Scattering
Cleaning in Manufacturing Areas
Bubble Point Test of Sterilization Grade Filter
Sealed Vials Leak Test
Aseptic Connection of Tubing
Cleaning & Sterilization of Stainless Steel Pressure Vessel
Cleaning of Production Area
Cleaning of Visual Inspection Area
Cleaning & Sterilization of Hand Gloves & Silicon Tubes
Cleaning of Pre-filter of LAF
Cleaning & Sterilization of Filtration Assembly
Authorized Entry into Sterile Production Area
Automatic Coating System
Compression Machine - Single Rotary
Behavior of Personnel Working in Clean Area
Blister Packing Machines
Bowie-Dick Test for Ensuring Absence of Air Pocket
Break Down Maintenance of Utilities & Equipment
Cad Mills
Calibration of Compounding Tank
Changeovers in Manufacturing and Packing Department
Alu-Alu Blister Pack Machine
Over Printing
Colloid Mills
Compression Machine - Double Rotary
De-blistering Machines
De-burring and De-dusting Machines
Sanitation of Drains
De-cartoning and Transfer of Ampoules to Washing Area
Defoilers
Dehumidifiers
Ampoule Filling and Sealing
Handling of Sieves & Screens
Metal Detector
Movement of Scrap in Production Block to Scrap Yard
Multi Mill
No Fill Detector (NFD)
Octagonal Blender
Washing of Equipment and Utensils
Opening and Closing of the Department
Opening and Closing the Production Department
Packing of Tablets & Capsules
Paste KeAPURUNle
Preparation of Cleaning and Sanitizing Solutions
Preparation of Disinfectant Solution
Production Start-up and Shut-down
Rapid Mixer Granulator
Recording of Differential Pressure
Recovery of Rejected Vials & Ampoules
Resuming Aseptic Area After Maintenance Activities
Stenciling of Shippers
Stirrer
Strip Packing Machine
Tablet Branding Machine
Tablet Granulation Compression and Coating
Tablet Inspection
Tablet Inspection Machine
Training of Operators
Usage & Storage of Sterile Garments
Vacuum Cleaner
Vibro Sifter
Working After Power Failure
$950.00
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$950.00
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Production - Oral Solid Dosage
Document
Labeling in Manufacturing Area
Compression Machine (Double Rotary)
Automatic Coating System (Neocota)
Drum Mixer
Die Blocking
Fluidized Bed Dryer
Break Down Maintenance of Utilities and Equipment
Cad Mill
Changeovers in Manufacturing and Packing Departments
Cleaning in Manufacturing Area
Colloid Mill
Compression Machine (Single Rotary)
Infrared Moisture Balance
Vacuum Cleaner
De-blistering Machine
De-burring and De-dusting Machine
Defoiler
Dehumidifier
Blister Packing Machine
Packing of Tablets & Capsules
Vibro Sifter
Double Cone Blender
Entry and Exit in Manufacturing Area
Entry and Exit of Visitors in Manufacturing Area
Tablet Granulation
Fumigation by Fogger Method in Production Area
Handling of Dies & Punches
Handling of FBD Filter Bag
Handling of Sieves and Screens
Handling of Stereos
Manufacturing of Tablets & Capsules
Alu-Alu Blister Pack Machine
Metal Detector
Multi Mill
No Fill Detector (NFD)
Octagonal Blender
Opening and Closing the Production Department
Over Printing
Paste Kettle
Preparation of Cleaning and Sanitizing Solutions
Production Start-up and Shut-down
Rapid Mixer Granulator
Recording of Differential Pressure
Sanitation of Drains
Stenciling of Shippers
Stirrer
Strip Packing Machine
Tablet Branding Machine
Tablet Inspection
Tablet Inspection Machine
$950.00
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$950.00
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Validation Protocols
Protocols
Disinfectant Validation
Glassware Cleaning Validation
Cleaning Validation
Purified Water System (PQ)
HVAC Validation (PQ)
Sterility Test Validation (Membrane Filtration)
Sterilized Sterility Test Media Storage Validation
Compressed Air Validation (PQ)
Autoclave Validation (PQ)
Sterility Test Validation (Direct Inoculation)
Process Validation (Tablet)
Media Fill Validation - Dry Powder Injection
Bacterial Endotoxin Test Validation
Sterilization and Depyrogenating Tunnel (PQ)
Sterility Test Validation
Dry Heat Sterilizer (DHS) Validation
Hold Time Study of In-process Samples
Media Fill Validation - Large Volume Parenteral (LVP)
Media Fill Validation - Small Volume Parenteral (SVP)
Water for Injection (WFI) System (PQ)
Microbial Limit Test (MLT) Validation
Sterilized Culture Media Storage Validation
$950.00
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$950.00
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Human Resources - Standard Operating Procedures (SOPs)
Document
Training of Personnel
Visitor Policy
Housekeeping of General Area
Pest and Rodent Control
Entry of the Employees and the Visitors in the Factory Premises
Fire Fighting
Garment Washing
Medical Checkup and Treatment
Security Persons
$950.00
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$950.00
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Microbiology Standard Operating Procedures (SOPs)
Document
Environmental Monitoring by Settling Plate Method
Sterilization by Autoclaving
Sterility Test
Microbial Limit Test of Packing Material
Glassware Cleaning
Personnel Monitoring in Aseptic Area
Sub-culturing of Microbial Cultures
Microbial Limit Test of Finished Product and Raw Material
Bacterial Endotoxin Test
General Guidelines for Microbiology Laboratory
Preparation of Disinfectant Solutions
Growth Promotion Test of Culture Media
Gram Staining & Motility of the Organisms
Environmental Monitoring by Air Sampler
Determination of Bacteriological Quality of Water
Sterility Failure Investigation
Qualification of Biological Indicators
Entry and Exit in Microbiological Testing Area
Microbial Limit Test of Compressed Air
Entry in Microbiology Section
Handling of Lysate
Disposal of Contaminated Material
Cleaning In Microbiology Section
$950.00
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$950.00
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