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)

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™ Vape, 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™ Vape is used for manufacturing. The core set of just the 23 SOPs and 7 Policies that cover the basics of manufacturing with InstantGMP™ MES or InstantGMP™ Vape are available at a discounted price. See pricing here.

A subset that is specific for Holding and Distribution Companies can be found at this link: SOP set for Holding and Distribution Companies

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
SOP-100* Purchase Requisition
SOP-101* Project Initiation
SOP-102* Standard Operating Procedures
SOP-103* Document Management System
SOP-104 Change Control
SOP-105 Adverse Events
SOP-106 Clinical Trial Initiation
SOP-107 Clinical Supply Material Release
SOP-108 Policies
SOP-110 Protocols
Quality System SOPs
SOP-203 Quality Agreement Preparation
SOP-204
Training Program
SOP-206 Investigations
SOP-207 Regulatory and Client Inspections
SOP-208* Deviations
SOP-209 Complaints
SOP-210 Corrective and Preventative Actions Program
SOP-211 Product Recalls
SOP-212* Program to Qualify Vendors
SOP-213 Document Review
SOP-214* Material Disposition
SOP-215* Tests
SOP-216* Methods
SOP-220 Stability Studies
SOP-221 Documentation Practices
Materials SOPs
SOP-300* Specifications
SOP-302* Material Types
SOP-303* Material Receipt
SOP-304* Material Status
SOP-305* Material Sampling
SOP-306* Material Inventory Control and Reconciliation
SOP-307 Packaging Component Inspection
SOP-308* Part # Assignment
SOP-310 Retain Samples
SOP-311 Clinical Supply Shipment
SOP-312 Material Shipment
SOP-314* In-Coming Materials Holding and Labeling
SOP-315* Holding and Labeling of In-Process Materials
SOP-316* Holding and Labeling of Packaging Components
SOP-317* Holding of Labels
SOP-318* Holding and Labeling of Finished Products
   
Facility and Equipment SOPs
SOP-400 Qualification of Equipment, Facility and Systems (IQ/OQ)
SOP-401 Performance Qualification of Systems (PQ)
SOP-402 Facility Access and Security
SOP-403 Warehouse and Production Area Cleaning and Maintenance
SOP-404 Facility Start Up and Shut Down
SOP-405 Equipment Receipt and System Manuals
SOP-406 Equipment and Room Logs and Status Tagging
SOP-407 Gowning and General Safety
SOP-408 Equipment and Utensil Cleaning and Storage
SOP-409 Equipment Cleaning Verification Program
SOP-410 Environmental Monitoring
SOP-411 Pest Control
SOP-412 Environmental Chambers and Storage
SOP-413 Equipment Calibration Program
SOP-415 Waste Control and Management
SOP-416 Grounds
SOP-417 Storage in Refrigerators or Freezers
   
Production SOPs
SOP-600* Master Production Record
SOP-601* Batch Production Record
   
Packaging and Labeling SOPs
 
SOP-700 Clinical Supply Label Preparation and Control
   
Safety SOPs
SOP-800 Hazardous Chemicals: Handling, Storage, and Disposal
SOP-801 Disaster Emergency Response
SOP-802 Safety Inspections
SOP-803 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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