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Our Full PRO Standard Operating Procedures (SOPs) set features over 115 policies and procedures for FDA regulated industries like biopharma, non-California cannabis, CBD,  dietary supplements, herbal products, kratom, and pharmaceuticals. The Full PRO SOP set is included in the Document Management System of InstantGMP PRO.

Policies for GMP Manufacturing Sites
POL-0100 Corporate Policies
POL-0101 Email Policy
POL-0102 Glossary
POL-0115 InstantGMP Personnel
POL-0118 Equipment Design Guideline
POL-0119 Utility Design Guideline
POL-0120 Leadership Policy
POL-0122 Written Procedures
POL-0124 Buildings, Facilities, Equipment Design, and Installation Policy
POL-0201 Confidentiality Policy
POL-0203 Service Provider Policy
POL-0207 Risk Assessment Policy
POL-0208 Project Initiation
POL-0300 InstantGMP Manufacturing
POL-0301 Electronic Records and Signatures Policy
POL-0302 Vendor Selection and Qualification
POL-0303 Material Control
POL-0304 Equipment Management
POL-0305 Facility Management
POL-0306* InstantGMP Production System Strategy
POL-0307 Purchasing Requirements
POL-0309 Production Personnel
POL-0500 Document Storage
POL-0501 Records
POL-0503 Training Policy
POL-0504 Change Management
POL-0506 Analytical Method Evaluation
POL-0507 Analytical Specification Evaluation
POL-0508 Regulatory Readiness
POL-0509 Quality Management System
POL-0510 Quality Audits
POL-0603 Records Retention and Disposition
Quality and Continuous Improvement Statement
General SOPs
SOP-0100 Purchase Requisition
SOP-0101 Project Initiation
SOP-0102 Standard Operating Procedures
SOP-0103 Document Management System
SOP-0104 Change Control
SOP-0105 Adverse Events
SOP-0106 Clinical Trial Initiation
SOP-0107 Clinical Supply Material Release
SOP-0108 Policies
SOP-0110 Protocols
Quality System SOPs
SOP-0202 Compliance with Certification and Regulatory Requirements
SOP-0203 Quality Agreement Preparation
SOP-0204 Training Program
SOP-0207 Regulatory and Client Inspections
SOP-0208 Deviation Investigations
SOP-0209 Material Complaints Handling
SOP-0210 Corrective and Preventative Actions Program
SOP-0211 Product Recalls
SOP-0212 Program to Qualify Vendors
SOP-0213 Finished Product Disposition
SOP-0214 Material Disposition
SOP-0215 Tests
SOP-0216 Methods
SOP-0220 Stability Studies
SOP-0221 Documentation Practices
SOP-0226 Accountability and Feedback Process
Material SOPs
SOP-0300 Specifications
SOP-0302 Material Types
SOP-0303* Material Receipt
SOP-0304 Material Status
SOP-0305 Material Sampling
SOP-0306 Material Inventory Control and Reconciliation
SOP-0307 Packaging Component Inspection
SOP-0308 Part Number Assignment
SOP-0310 Retain Samples
SOP-0311 Clinical Supply Shipment to Study Sites
SOP-0312 Material Shipment
SOP-0314 Incoming Materials Holding and Labeling
SOP-0315 Holding and Labeling of In-Process Materials
SOP-0316 Holding and Labeling of Packaging Components
SOP-0317 Holding of Labels
SOP-0318* Holding and Labeling of Finished Products
Facility and Equipment SOPs
SOP-0400 Qualification of Equipment, Facility, and Systems (IQ/OQ)
SOP-0401 Performance Qualification of Systems (PQ)
SOP-0402 Facility Access and Security
SOP-0403 Warehouse and Production Area Cleaning and Maintenance
SOP-0404 Facility Start-up and Shut-down
SOP-0405 Equipment Receipt and System Manuals
SOP-0406 Equipment and Room Logs and Status Tagging
SOP-0407 Gowning and General Safety
SOP-0408 Equipment and Utensil Cleaning and Storage
SOP-0409 Equipment Cleaning Verification Program
SOP-0410 Environmental Monitoring
SOP-0411 Pest Control
SOP-0412 Environmental Chambers and Storage
SOP-0413 Equipment Calibration Program
SOP-0415 Waste Control Management
SOP-0416 Storage in Refrigerators or Freezers
SOP-0417 Clean Room Cleaning
SOP-0418 Grounds
SOP-0420 Facility Management and Modification
SOP-0421 Equipment Installation
SOP-0422 Utility Management Program
SOP-0423 Change Control for Facility, Equipment, and Utilities
SOP-0426 Products Returns
SOP-0427 Class 100 Clean Room Cleaning
Computer System SOPs
SOP-0500 Computer System Inventory
SOP-0501 Computer System Operation
SOP-0502 Computer System Security
SOP-0503 Computer System Validation
SOP-0504 Electronic Signatures
Production SOPs
SOP-0600 Master Production Record
SOP-0601 Batch Production Record
SOP-0602 Inventory Management During Batch Production
Packaging and Labeling SOPs
SOP-0700 Clinical Supply Label Preparation and Control
Safety SOPs
SOP-0800 Hazardous Chemicals: Handling, Storage, and Disposal
SOP-0801 Disaster Emergency Response
SOP-0802 Safety Inspections
SOP-0803 Equipment Lock/Out and Tag/Out
Format Templates
TMPL-0001 Policy Format
TMPL-0100 SOP Format

STANDARD OPERATING PROCEDURES

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