Full PRO SOP Set
Our Full PRO Standard Operating Procedures (SOPs) set features over 120+ policies and procedures for FDA regulated industries like biopharma, 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-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 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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