January 25, 2016

Holding/Distribution Companies SOPs & Policies

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 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. 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 ensure that drugs and supplements are designed and produced in accordance with cGMPs.

InstantGMP™ recommends the set shown below for Holding and Distribution companies:

 SOP 0102 Standard Operating Procedures

 SOP 0103 Document Management System

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

For more information, contact Robert Pochadt at: rpochadt@InstantGMP.com or call (215) 968-5414.