Full PRO SOP Set

Standard Operating Procedure Full Set

Standard Operating Procedure (SOPs) Full Set

Our Full PRO Standard Operating Procedures (SOPs) set features over 120+ policies and procedures for GMP regulated industries like biotech, dietary supplements, herbal products, kratom, and pharmaceuticals. The Full PRO SOP set is included in the Document Management System of InstantGMP™ PRO and InstantGMP™ MES.

Standard Operating Procedure (SOPs) Full Set

View the growing list of SOPs InstantGMP has available. All SOPs are included in InstantGMP PRO.
  • Policies for GMP Manufacturing Sites
  • General SOPs
  • Quality System SOPs
  • Material SOPs
  • Facility & Equipment SOPs
  • Computer System SOPs
  • Production SOPs
  • Packaging & Labeling SOPs
  • Safety SOPs
  • Format Templates

    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-0104 Change Control
    • SOP-0105 Adverse Events
    • SOP-0106 Clinical Trial Initiation
    • SOP-0107 Clinical Supply Material Release
    • SOP-0108 Policies
    • SOP-0110 Protocols
    • SOP-0116 Electronic Document Management

    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 & 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 & 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

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