Regulation of Cell Therapy Products

The module reviews a history of human cells, tissues, cellular and tissue-based products (HCT/Ps), and U.S. Food and Drug Administration (FDA) oversight. It describes which cells and tissues are subject to regulation and introduces the FDA’s current Good Tissue Practice (cGTP) regulations. The module also explains the differences between 351 and 361 HCT/Ps.

Recommended Use: Required
ID (Language): 21797 (English)
Author(s): Victoria Lake, BA, BSc, RAC - Sound Regulatory Consulting, LLC

The module describes the purpose and scope of FDA regulations for HCT/Ps at 21 CFR 1271. In addition, it identifies key cGTP requirements for donor eligibility and manufacturing establishments.

Recommended Use: Required
ID (Language): 21798 (English)
Author(s): Lou Bartolo, DNP, MSN, RN - NMDP; Kathy Loper, MHS, MT(ASCP) - NMDP

The module describes when and how the FDA regulations for cGTP apply to different HCT/Ps. It discusses exemptions, alternatives, and examples of cGTP application to various product types. In addition, the module reviews manufacturing regulations and their application.

Recommended Use: Required
ID (Language): 21799 (English)
Author(s): Paige McKibbon, MS - NMDP; Jared Schuster, BS, HTL(ASCP), CABP - NMDP

This module discusses donor eligibility requirements under 21 CFR 1271, Subpart C. It describes the distinction between donor screening and testing and identifies the applicable documentation that should accompany an HCT/P. The module also identifies situations where donor eligibility exceptions may apply.

Recommended Use: Required
ID (Language): 21800 (English)
Author(s): Beth Kuker, MS - NMDP; Madalena Gryncewicz, MS - NMDP

The module details the core cGTP requirements for establishing and maintaining quality programs, including those specific to personnel, procedures, process changes, and process validation. The module also includes a discussion of the procedures for managing complaints.

Recommended Use: Required
ID (Language): 21801 (English)
Author(s): Kelly Bryant, BSN, RN - NMDP

The module discusses how current cGTP regulations dictate facility design and construction. It discusses how the environmental control of the manufacturing site can be monitored and describes the regulations for cleaning, maintaining, and tracing the equipment used in the manufacture of HCT/Ps. In addition, the module explains the rules applicable to the receipt and verification of supplies and reagents.

Recommended Use: Required
ID (Language): 21802 (English)
Author(s): Laurel Anderson, BS, MT(ASCP) - NMDP; Stephanie Thompson, BS, ASQ (CQA) - NMDP

The module discusses the regulations that impact HCT/P labeling processes. It explains the process control methods for storing HCT/Ps to prevent cross-contamination and improper release. In addition, the module describes procedures for pre-distribution and shipping of HCT/Ps and the safeguards used to preserve record integrity and product tracking.

Recommended Use: Required
ID (Language): 21803 (English)
Author(s): Laurel Anderson, BS, MT(ASCP) - NMDP; Stephanie Thompson, BS, ASQ (CQA) - NMDP

The module describes the reporting requirements of an adverse reaction and a deviation per FDA 21 CFR 1271. It also explains how to evaluate an adverse reaction for potential root causes.

Recommended Use: Required
ID (Language): 21804 (English)
Author(s): Erica Agy, BS - Fred Hutchinson Cancer Center; Angela Ondo, BS, MT(ASCP) - Johns Hopkins Medicine

The module reviews the regulatory tiers for 361 and 351 HCT/Ps, along with each kick-down factor. It describes the application of current Good Manufacturing Practices (cGMPs) and cGTP to the regulation of 351 HCT/Ps.

Recommended Use: Required
ID (Language): 21805 (English)
Author(s): Victoria Lake, BA, BSc, RAC - Sound Regulatory Consulting, LLC