Holding/Distribution Companies SOPs
When starting a Holding and Distribution company, it’s easy to think that Good Manufacturing Practices (GMP) are the responsibility of the contract manufacturers or private label suppliers who produce pharmaceuticals and dietary supplements. They are responsible, but that’s not quite the complete picture in the eyes of the FDA.
The FDA requires compliance with GMPS in manufacturing, packaging, labeling, and holding operations for dietary supplements and pharmaceuticals. That means the FDA expects that the distributor of the final product that reaches the consumer will also have responsibility for assuring the products they receive comply with all the GMP requirements. The Holding and Distribution company has to ensure that packaging and labeling was done as specified in the master manufacturing record, and ensure the quality of the product that reaches the market. Failure to comply means the FDA will consider these products to be adulterated.
Fortunately, InstantGMP™ provides a set of Policies and Standard Operating Procedures that provide a roadmap to compliance for Holding/Distribution Companies. When used in holding and distributing pharmaceutical or dietary supplement products, they ensure that all products will meet their requirements for potency, purity, efficacy, safety, and performance. They also guarantee that drugs and supplements are designed and produced in accordance with cGMPs. Fill out the form or contact us to learn more!
InstantGMP recommends the set shown below for Holding and Distribution companies:
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 |
STANDARD OPERATING PROCEDURES
To contact us, use this form or email us at info@instantgmp.com