GMP Manufacturing SOPs
The FDA mandates that companies that manufacture and/or distribute dietary supplements, herbal products (like Hemp/CBD/Kratom) & pharmaceuticals implement and follow a full set of SOPs as part of a quality system. A full set of industry specific manufacturing SOPs is available to work in coordination with your existing SOPs or your quality systems at your company. They are written to allow you to add them into your current quality system with little effort on your part. This allows your manufacturing operation to quickly come into compliance with the electronic systems with a minimum of disruption. The MES Full Set of SOPs work great for companies using paper documentation and can be uploaded to a Document Management System.
The full set includes over 115 SOPs, Policies and templates that provides a quality system for any GMP manufacturing site. Fill out the form or give us a call to learn more!
SOP 0102 Standard Operating Procedures
SOP 0103 Document Management System
| 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 |