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Full PRO SOP Set

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Our Full PRO Standard Operating Procedures (SOPs) set features over 120+ policies and procedures for FDA regulated industries like biopharma, 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 0116 Electronic Document Management
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-0208Project Initiation
POL-0300InstantGMP Manufacturing
POL-0301Electronic Records and Signatures Policy
POL-0302Vendor Selection and Qualification
POL-0303Material Control
POL-0304Equipment Management
POL-0305Facility Management
POL-0306*InstantGMP Production System Strategy
POL-0307Purchasing 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-0100Purchase Requisition
SOP-0101Project Initiation
SOP-0102Standard Operating Procedures
SOP-0104Change Control
SOP-0105Adverse Events
SOP-0106Clinical Trial Initiation
SOP-0107Clinical Supply Material Release
SOP-0108Policies
SOP-0110Protocols
SOP-0116Electronic Document Management
Quality System SOPs
SOP-0202Compliance with Certification and Regulatory Requirements
SOP-0203Quality Agreement Preparation
SOP-0204Training Program
SOP-0207Regulatory and Client Inspections
SOP-0208Deviation Investigations
SOP-0209Material Complaints Handling
SOP-0210Corrective and Preventative Actions Program
SOP-0211Product Recalls
SOP-0212Program to Qualify Vendors
SOP-0213Finished Product Disposition
SOP-0214Material Disposition
SOP-0215Tests
SOP-0216Methods
SOP-0220Stability Studies
SOP-0221Documentation Practices
SOP-0226Accountability and Feedback Process
Material SOPs
SOP-0300Specifications
SOP-0302Material Types
SOP-0303*Material Receipt
SOP-0304Material Status
SOP-0305Material Sampling
SOP-0306Material Inventory Control and Reconciliation
SOP-0307Packaging Component Inspection
SOP-0308Part Number Assignment
SOP-0310Retain Samples
SOP-0311Clinical Supply Shipment to Study Sites
SOP-0312Material Shipment
SOP-0314Incoming Materials Holding and Labeling
SOP-0315Holding and Labeling of In-Process Materials
SOP-0316Holding and Labeling of Packaging Components
SOP-0317Holding 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-0600Master Production Record
SOP-0601Batch Production Record
SOP-0602Inventory 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

STANDARD OPERATING PROCEDURES

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