June 3, 2019

Full PRO SOP Set

Our Full PRO Standard Operating Procedures (SOPs) set features over 115 policies and procedures for FDA regulated industries like biopharma, non-California cannabis, CBD,  dietary supplements, herbal products, kratom, and pharmaceuticals. The Full PRO SOP set is included in the Document Management System of InstantGMP™ PRO

 SOP 0102 Standard Operating Procedures
 SOP 0103 Document Management System

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Policies for GMP Manufacturing Sites
POL-0100Corporate Policies
POL-0101Email Policy
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-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
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-0220Stability Studies
SOP-0221Documentation Practices
SOP-0226Accountability and Feedback Process
Material SOPs
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-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