InstantGMP: Manufacturing Execution System for GMP Manufacturing

Standard Operating Procedures

The quality assurance experts at InstantGMP™ are pleased to make these examples of SOPs available for download.

SOP: Stability Protocol Guidance SOP: Stability Protocol Guidance (149 KB)

SOP-0102 Standard Operating Procedures SOP-0102 Standard Operating Procedures (73 KB)

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SOP-0103 Document Management System SOP-0103 Document Management System (195 KB)

The full set of manufacturing SOPs is designed to work in coordination with existing SOPs and legacy 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. Since the requirements of these SOPs are built into InstantGMP™ MES and InstantGMP™ QSR, implementation and training is easy. 

The full set includes over 90 SOPs, Policies and templates that provides a quality system for any GMP manufacturing site.  This set includes the 23 SOPs and 7 Policies that are essential for a quality system where InstantGMP™ MES or InstantGMP™ QSR is used for manufacturing. A core set of 23 SOPs and 7 Policies that cover just the basics of manufacturing with InstantGMP™ MES or InstantGMP™ QSR are available at a discounted price. See pricing here.

Policies for GMP Manufacturing Sites
POL-0100 Corporate Policies
POL-0101 Email Policy
POL-0102 Glossary 
POL-0115 InstantGMP Personnel
POL-0201 Confidentiality Policy
POL-0203 Service Provider 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-0306* InstantGMP Production System Strategy
POL-0307* Purchasing Requirements
POL-0309 Production Personnel
POL-0310 Production Facilities and Buildings
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 Policy
POL-0510 Quality Audits
POL-0630 Records Retention and Disposition
General SOPs
S100* Purchase Requisition
S101* Project Initiation
S102* Standard Operating Procedures
S103* Document Management System
S104 Change Control
S105 Adverse Events
S106 Clinical Trial Initiation
S107 Clinical Supply Material Release
S108 Policies
S110 Protocols
Quality System SOPs
S203 Quality Agreement Preparation
S204
Training Program
S206 Investigations
S207 Regulatory and Client Inspections
S208* Deviations
S209 Complaints
S210 Corrective and Preventative Actions Program
S211 Product Recalls
S212* Program to Qualify Vendors
S213 Document Review
S214* Material Disposition
S215* Tests
S216* Methods
S220 Stability Studies
S221 Documentation Practices
Materials SOPs
S300* Specifications
S302* Material Types
S303* Material Receipt
S304* Material Status
S305* Material Sampling
S306* Material Inventory Control and Reconciliation
S307 Packaging Component Inspection
S308* Part # Assignment
S310 Retain Samples
S311 Clinical Supply Shipment
S312 Material Shipment
S314* In-Coming Materials Holding and Labeling
S315* Holding and Labeling of In-Process Materials
S316* Holding and Labeling of Packaging Components
S317* Holding of Labels
S318* Holding and Labeling of Finished Products
   
Facility and Equipment SOPs
S400 Qualification of Equipment, Facility and Systems (IQ/OQ)
S401 Performance Qualification of Systems (PQ)
S402 Facility Access and Security
S403 Warehouse and Production Area Cleaning and Maintenance
S404 Facility Start Up and Shut Down
S405 Equipment Receipt and System Manuals
S406 Equipment and Room Logs and Status Tagging
S407 Gowning and General Safety
S408 Equipment and Utensil Cleaning and Storage
S409 Equipment Cleaning Verification Program
S410 Environmental Monitoring
S411 Pest Control
S412 Environmental Chambers and Storage
S413 Equipment Calibration Program
S415 Waste Control and Management
S416 Grounds
S417 Storage in Refrigerators or Freezers
   
Production SOPs
S600* Master Production Record
S601* Batch Production Record
   
Packaging and Labeling SOPs
 
S700 Clinical Supply Label Preparation and Control
   
Safety SOPs
S800 Hazardous Chemicals: Handling, Storage, and Disposal
S801 Disaster Emergency Response
S802 Safety Inspections
S803 Equipment Lock/Out and Tag/Out
   
Format Templates
TMPL-0001 Policy Format
TMPL-0100 SOP Format

* Policies and SOPs that are needed for InstantGMP™ manufacturing sites.

The Core SOPs or the full set of SOPs are available for purchase. For more information, contact Robert Pochadt at: or Purchase Now through the link below:

InstantGMP SOPs For Sale

InstantGMP SOPs For Sale


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