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Full MES SOP Set

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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!

Full MES SOP Set SOP 0102 Standard Operating Procedures

Full MES SOP Set SOP 0103 Document Management System

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

 

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