Current Good Tissue Practice (cGTP) — 21 CFR Part 1271 Subpart D

Current Good Tissue Practice (cGTP) requirements establish the manufacturing safeguards applicable to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulated under 21 CFR Part 1271 Section 361.

cGTP requirements are codified in 21 CFR Part 1271 Subpart D and apply to establishments that manufacture HCT/Ps.

These safeguards form part of the broader Biologic Product Portfolio and are designed to prevent the introduction, transmission, or spread of communicable disease.

Current Good Tissue Practice cGTP framework under 21 CFR Part 1271 Subpart D showing facility controls, personnel oversight, donor screening, processing controls, labeling traceability, and inspection authority
Educational overview of manufacturing and quality system safeguards required under 21 CFR Part 1271 Subpart D. Registration does not constitute FDA approval.

Purpose of cGTP Requirements

cGTP standards require establishments to implement appropriate methods, facilities, and controls during:

  • Recovery
  • Processing
  • Storage
  • Labeling
  • Packaging
  • Distribution

The regulatory objective is to ensure HCT/Ps are not contaminated and do not become contaminated during manufacturing activities.

Scope of Subpart D — Manufacturing Controls

Subpart D requires establishments to maintain written procedures and quality systems addressing:

  • Environmental control and monitoring
  • Equipment validation and maintenance
  • Supply chain control
  • Process validation (where applicable)
  • Recordkeeping and traceability
  • Complaint handling procedures

These controls operate alongside donor eligibility requirements within the 21 CFR 1271 Subparts A–D regulatory structure.

Core Quality System Elements

cGTP compliance typically includes:

  • Standard operating procedures (SOPs)
  • Personnel training programs
  • Lot identification and traceability systems
  • Deviation investigation protocols
  • Corrective and preventive action (CAPA) systems

Establishments must maintain records sufficient to track each HCT/P from donor to final distribution.

Relationship to Section 361 Eligibility

Qualification under Section 361 requires compliance with:

Failure to comply with Subpart D requirements may affect regulatory standing under Section 361.

Regulatory & Enforcement Considerations

FDA inspections may evaluate:

  • Environmental controls
  • Documentation integrity
  • Chain-of-custody tracking
  • Deviation handling
  • Quality oversight systems

Observations related to cGTP deficiencies may result in warning letters, corrective action requirements, or other regulatory measures.

FDA Enforcement Overview

Professional Documentation & Evaluation Pathway

Not By Chance Life LLC provides structured regulatory education and credential-based documentation coordination for licensed healthcare professionals evaluating HCT/P regulatory positioning.

Structured documentation review is available through the Structured Supplier Evaluation Process.

Initiate Credential Review

Regulatory Notice

Registration under 21 CFR Part 1271 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.

This content is provided for educational purposes only and does not constitute legal or medical advice.