An Introduction to Current Good Tissue Practice (GTP)

Beatrice Huey

Course description

The US FDA’s current Good Tissue Practice regulations constitute a significant compliance challenge for the Human Tissue Industry. This course is intended to provide hands-on training for anyone who works for human cell, tissue, and cellular and tissue-based products companies which must comply with CGTP.

In this intensive training, we will review the Public Health Service Act (PHS), the federal Food, Drug, and Cosmetic Act (FD&C) and their regulatory authority. Discussion of the regulations and available guidance will be covered including Section 351 and 361 products and determination of minimal manipulation. Deep dive into cGTPs, as outlined in Subpart D, including facilities, environmental controls, equipment, supplies and reagents, recovery, processing and process controls, labeling, storage, receipt, pre-distribution shipment, and distribution. The course will provide tips on how to implement these regulations in a practical format. Participants in this course will gain a detailed understanding of what is required to achieve and maintain compliance with these important regulations.

Upon completion of this course, you will be able to:

• Determine if your establishment is regulated solely under section 361 of the Public Health Services and the regulations in 21 CFR Part 1271 or if your HCT/Ps are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act and/or the federal Food, Drug, and Cosmetic Act.
• Determine if you are required to register and list your product.
• Identify the requirements you must follow if you perform only some manufacturing operations.
• List the “core” GTP requirements that place specific emphasis on procedures and practices to recover, process, store, label, package, and distribute HCT/Ps.
• Explain the additional requirements of reporting and labeling.
• Explain the exceptions to Subpart A.
• Summarize what a quality program consists of.
• Outline and execute a realistic plan for achieving and maintaining compliance with these requirements.