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 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-0100Corporate Policies
POL-0102Glossary
POL-0201Confidentiality Policy
POL-0203Service Provider Policy
POL-0303Material Receipt
POL-0304Equipment Management
POL-0307Purchasing Requirements
POL-0310Production Facilities and Buildings
POL-0315Supplier Qualification for Holding/Distribution Companies
POL-0316Material Control for Holding/Distribution Companies
POL-0317Equipment Management for Holding/Distribution Companies
POL-0318Facility Management for Holding/Distribution
POL-0319Purchasing Requirements for Holding/Distribution
POL-0320Holding/Distribution Personnel
POL-0500Document Storage Policy
POL-0503Training Policy
POL-0504Change Management
POL-0508Regulatory Readiness
POL-0509Quality Management Policy
POL-0510Quality Audits
POL-0603Records Retention and Disposition
General SOPs for GMP Holding and Distribution Companies
SOP-102Standard Operating Procedures
SOP-103Document Management System
SOP-104Change Control
SOP-108Policies
SOP-110Protocols
Quality System SOPs for GMP Holding and Distribution Companies
SOP-203Quality Agreement Preparation
SOP-204Training Program
SOP-206Investigations
SOP-207Regulatory and Client Inspections
SOP-208Deviations
SOP-209Material Complaints Handling
SOP-210Corrective and Preventative Actions Program
SOP-211Product Recalls
SOP-212Program to Qualify Vendors
SOP-213Document Review
SOP-221Documentation Practices
Materials SOPs for GMP Holding and Distribution Companies
SOP-306Material Inventory Control and Reconciliation
SOP-307Packaging Component Inspection
SOP-310Retain Samples
SOP-312Material Shipment
SOP-314In-Coming Materials Holding and Labeling
SOP-315Holding and Labeling of In-Process Materials
SOP-316Holding and Labeling of Packaging Components
SOP-317Holding of Labels
SOP-318Holding and Labeling of Finished Products
Facility and Equipment SOPs for GMP Holding and Distribution Companies
SOP-400Qualification of Equipment, Facility and Systems (IQ/OQ)
SOP-401Performance Qualification of Systems (PQ)
SOP-402Facility Access and Security
SOP-403Warehouse and Production Area Cleaning and Maintenance
SOP-404Facility Start Up and Shut Down
SOP-405Equipment Receipt and System Manuals
SOP-406Equipment and Room Logs and Status Tagging
SOP-407Gowning and General Safety
SOP-408Equipment and Utensil Cleaning and Storage
SOP-409Equipment Cleaning Verification Program
SOP-410Environmental Monitoring
SOP-411Pest Control
SOP-412Environmental Chambers and Storage
SOP-413Equipment Calibration Program
SOP-414Equipment Maintenance Program
SOP-415Waste Control and Management
SOP-417Storage in Refrigerators or Freezers
SOP-418Grounds
SOP-426Product Returns
Safety SOPs for GMP Holding and Distribution Companies
SOP-800Hazardous Chemicals: Handling, Storage, and Disposal
SOP-801Disaster Emergency Response
SOP-802Safety Inspections
SOP-803Equipment Lock/Out and Tag/Out
Format Templates
TMPL-0001Policy Format
TMPL-0100SOP Format

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