Product Acceptance and Release SOP Templates
Compliance Documentation Toolkit Based on 21 CFR 117 for Holding and Distribution of Food Products
To establish FDA-compliant standard operating procedures (SOPs) for the acceptance, inspection, release, and distribution of imported food products in accordance with 21 CFR 117 Subparts B and E, this documentation set provides a comprehensive SOP package for importers, distributors, or warehouse operators seeking to verify product conformity prior to market entry.
Scope of Work
Product Acceptance SOP Program
Develop and standardize SOPs governing acceptance criteria for incoming finished food products. Includes procedures for product inspection, documentation verification, lot tracking, and non-
conformance management.
Inspection & Receiving Procedures
Define procedures for incoming shipment inspections, including review of product identity, specifications, packaging, labeling, and compliance with supplier agreements.
- Includes:
- • Inspection Checklists, Bill of Lading Verification, Receiving Logs
Laboratory Testing and Sampling Protocols
Establish procedures for collecting, handling, and submitting samples for microbiological, chemical, and physical testing as part of pre-distribution safety verification.
- Includes:
- • Material Testing Schedules, Sample Submission Logs
Retention Sample Management
Set SOPs for reserve sample collection and retention to support quality assurance and post-distribution traceability.
- Includes:
- • Retention Sample SOP, Reserve Sample Register
Non-Conformance and Product Hold Procedures
Create protocols for identifying and segregating non-conforming products.
- Includes:
- • Rejection Forms, Hold Tags, Quarantine Logs, Disposal Documentation
Product Release Criteria and Documentation
Define release approval process for finished products prior to distribution, including specification validation and traceability documentation.
- Includes:
- • Product Release SOPs, Monitoring Records, Hold/Release Logs
Specification and Traceability Program
Establish documentation for finished product and packaging specifications as well as internal traceability tracking from receipt to release.
- Includes:
- • Specification Registers, Packaging Specs, Trace Logs
Corrective Action and CAPA Response
Implement standard procedures for handling complaints, deviations, and audit findings related to noncompliant product conditions.
- Includes:
- • CAPA Reports, Investigation Logs
Deliverables
Product Acceptance SOP Toolkit
Includes fully editable SOPs, templates, and compliance documentation organized into key control areas:
- • Incoming Shipment Inspection
- • Testing and Sampling
- • Retention Sample Collection
- • Non-Conformance Management
- • Product Release Approval
- • Specification and Traceability Records
- • Corrective Action and CAPA Response
Forms, Registers, and Checklists
Includes the following pre-formatted tools:
- • Inspection Checklists
- • Sample Submission Logs
- • Rejection Forms and Tags
- • Product Release Records
- • Specification Sheets
- • Trace Logs
- • CAPA Templates
Fees and Subscriptions
| Package | Description | Fee |
|---|---|---|
| SOP Template Toolkit | One-time delivery of FDA-aligned SOPs and compliance records | $770.00 USD |
Ideal For:
Brand Owners, Importers, third-party logistics providers, and distributors seeking ready-to-use, FDA-aligned documentation for the proper acceptance, handling, and release of imported food products in compliance with 21 CFR 117.