InstantGMP: Manufacturing Execution System for GMP Manufacturing

Additional Standard Operating Procedures Available

InstantGMP™ can provide a complete set of GMP manufacturing SOPs and polices that will make compliance easy for any GMP manufacturing operation .When is licensed, manufacturing Policies and SOPs are provided as part of the installation process.  The additional manufacturing SOPs and policies in the list below are designed to work in any GMP manufacturing environment or to augment existing legacy quality systems.  Please contact us for pricing.

Policies that are available for purchase
POL-0100 Corporate Policies
POL-0101 Email Policy
POL-0201 Confidentiality Policy
POL-0203 Service Provider Policy
POL-0503 Training Policy
POL-0504 Change Management
POL-0506 Analytical Method Evaluation
POL-0507 Analytical Specification Evaluation
POL-0508 Regulatory Readiness
POL-0510 Quality Audits
General SOPs that are available for purchase
S104 Change Control
S105 Adverse Events
S106 Clinical Trail Initiation
S107 Clinical Supply Material Release
S108 Policies
S110 Protocols
Quality System SOPS that are available for purchase
S203 Quality Agreement Preparation
S204
Training Program
S206 Investigations
S207 Regulatory and Client Inspections
S208 Deviations
S210 Corrective and Preventative Actions Program
S212 Program to Qualify Vendors
S213 Document Review
S220 Stability Studies
Materials SOPS that are available for purchase
S307 Packaging Component Inspection
S310 Retain Samples
S311 Clinical Supply Shipment
S312 Material Shipment
Facility and Equipment SOPs that are available for purchase
S400 Qualification of Equipment, Facility and Systems (IQ/OQ)
S401 Performance Qualification of Systems (PQ)
S402 Facility Access and Security
S403 Warehouse and Production Area Cleaning and Maintenance
S404 Facility Startup and Shut Down
S405 Equipment Receipt and System Manuals
S406 Equipment and Room Logs and Status Tagging
S407 Gowning and General Safety
S408 Equipment and Utensil Cleaning and Storage
S409 Equipment Cleaning Verification Program
S410 Environmental Monitoring
S411 Pest Control
S412 Environmental Chambers and Storage
S413 Equipment Calibration Program
   
Packaging and Labeling SOPs that are available for purchase
 
S700 Clinical Supply Label Preparation and Control
   
Safety SOPs that are available for purchase
S800 Hazardous Chemicals: Handling, Storage, and Disposal
S801 Disaster Emergency Response
S802 Safety Inspections
S803 Equipment Lock/Out and Tag/Out
   
Formats that are available for purchase
TMPL-0001 Policy Format
TMPL-0100 SOP Format

These additional SOPs cover all other aspects of GMP manufacturing that are not covered by InstantGMP™.
For pricing, contact Rick at:

                                                
     
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