Holding/Distribution Companies SOPs

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Holding/Distribution Companies SOPs

The FDA requires compliance with GMPs in manufacturing, packaging, labeling, and holding operations for biotech, dietary supplements and pharmaceuticals. The distributor of the final product is responsible for assuring the products consumers receive comply with all the GMP requirements. The Holding and Distribution company ensures packaging and labeling are done as specified in the master manufacturing record and the quality of the product that reaches the market. Failure to comply means the FDA will consider these products to be adulterated.

InstantGMP™ provides a set of Policies and Standard Operating Procedures to provide a roadmap to compliance for Holding/Distribution Companies. When Polices and SOPs are used in holding and distributing companies, they ensure products will meet the storage requirements for biotech, pharmaceutical and dietary supplement products in accordance with cGMPs.

View Sample SOPs for Holding and Distribution Companies

Holding/Distribution Companies SOPs

View the Growing List of SOPs InstantGMP has Available. All SOPs are Included with InstantGMP PRO.
  • Policies for GMP Holding and Distribution Companies
  • General SOPs for GMP Holding and Distribution Companies
  • Quality System SOPs for GMP Holding and Distribution Companies
  • Materials SOPs for GMP Holding and Distribution Companies
  • Facility and Equipment SOPs for GMP Holding and Distribution Companies
  • Safety SOPs for GMP Holding and Distribution Companies
  • Format Templates

    Policies for GMP Holding and Distribution Companies

    • POL-0100 Corporate Policies
    • POL-0102 Glossary
    • POL-0201 Confidentiality Policy
    • POL-0203 Service Provider Policy
    • POL-0303 Material Receipt
    • POL-0304 Equipment Management
    • POL-0307 Purchasing Requirements
    • POL-0310 Production Facilities and Buildings
    • POL-0315 Supplier Qualification for Holding/Distribution Companies
    • POL-0316 Material Control for Holding/Distribution Companies
    • POL-0317 Equipment Management for Holding/Distribution Companies
    • POL-0318 Facility Management for Holding/Distribution
    • POL-0319 Purchasing Requirements for Holding/Distribution
    • POL-0320 Holding/Distribution Personnel
    • POL-0500 Document Storage Policy
    • POL-0503 Training Policy
    • POL-0504 Change Management
    • POL-0508 Regulatory Readiness
    • POL-0509 Quality Management Policy
    • POL-0510 Quality Audits
    • POL-0603 Records Retention and Disposition

    General SOPs for GMP Holding and Distribution Companies

    • SOP-102 Standard Operating Procedures
    • SOP-103 Document Management System
    • SOP-104 Change Control
    • SOP-108 Policies
    • SOP-110 Protocols

    Quality System SOPs for GMP Holding and Distribution Companies

    • SOP-203 Quality Agreement Preparation
    • SOP-204 Training Program
    • SOP-206 Investigations
    • SOP-207 Regulatory and Client Inspections
    • SOP-208 Deviations
    • SOP-209 Material Complaints Handling
    • SOP-210 Corrective and Preventative Actions Program
    • SOP-211 Product Recalls
    • SOP-212 Program to Qualify Vendors
    • SOP-213 Document Review
    • SOP-221 Documentation Practices

    Materials SOPs for GMP Holding and Distribution Companies

    • SOP-306 Material Inventory Control and Reconciliation
    • SOP-307 Packaging Component Inspection
    • SOP-310 Retain Samples
    • 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 for GMP Holding and Distribution Companies

    • 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-414 Equipment Maintenance Program
    • SOP-415 Waste Control and Management
    • SOP-417 Storage in Refrigerators or Freezers
    • SOP-418 Grounds
    • SOP-426 Product Returns

    Safety SOPs for GMP Holding and Distribution Companies

    • 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

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