HCT/P Documentation Checklist | 21 CFR 1271 Review Guide

HCT/P Documentation Review Checklist

This checklist outlines documentation categories commonly reviewed when evaluating Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) within the framework of 21 CFR Part 1271.

The purpose of this checklist is to support transparency and informed sourcing by identifying key records typically associated with donor eligibility, processing controls, and product traceability.

1. Donor Eligibility Documentation

  • ☐ Donor eligibility determination statement
  • ☐ Infectious disease testing results
  • ☐ Donor screening (medical and social history)
  • ☐ Donor identification and recovery date

Reference: Donor Eligibility — 21 CFR 1271 Subpart C

2. Processing and Handling Documentation

  • ☐ Description of processing methods
  • ☐ Preservation and storage procedures
  • ☐ Environmental and handling controls
  • ☐ Lot or batch identification records

Reference: Minimal Manipulation — 21 CFR 1271.3(f)

3. Intended Use and Product Description

  • ☐ Product labeling and description
  • ☐ Intended use aligned with tissue function
  • ☐ Structural or cellular tissue classification

Reference: Homologous Use — 21 CFR 1271.3(c)

4. Chain of Custody and Traceability

  • ☐ Unique identifier (lot/batch tracking)
  • ☐ Chain of custody documentation
  • ☐ Storage and handling logs
  • ☐ Distribution records

Reference: cGTP — 21 CFR 1271 Subpart D

5. Establishment and Regulatory Information

  • ☐ FDA establishment registration
  • ☐ Product listing information
  • ☐ Available inspection or compliance records

Reference: 21 CFR Part 1271 Overview

How This Checklist Is Used

This checklist is intended as an educational reference to support documentation review. It does not establish regulatory status, and availability of documentation may vary by manufacturer or distributor.

Review should be conducted by licensed professionals familiar with applicable regulatory standards.

Regulatory Notice

This information is for educational purposes only.

Not evaluated by the FDA.

Not intended to diagnose, treat, cure, or prevent any disease.

For use by licensed medical professionals.