January 25, 2023
A joint working group of AABB and the International Society for Cell and Gene Therapy (ISCT) released a new Good Tissue Practice (GTP) Interpretive Tool on both the AABB and ISCT websites.
The joint working group developed the AABB/ISCT (GTP) Interpretive Tool to educate those in the biotherapies community about the interpretation of GTP requirements and how best to prepare for FDA inspections of establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The AABB/ISCT GTP Interpretative Tool provides section-by-section guidance specific to the needs of biotherapies programs to help them achieve regulatory compliance and prepare for unannounced FDA inspections. The tool consolidates references and provides links that aid in determining the correct regulatory pathways for Section 361-based products during early and late-stage development, excluding reproductive applications.
Furthermore, the AABB/ISCT (GTP) Interpretive Tool includes an introduction to the use of the tool and a list of abbreviations used throughout the content. The tabular format includes the individual GTP regulation, GTP guidance references, GTP considerations that simplify the regulation content and an “Additional Resources” section that contains scientific literature and other relevant documents related to the subject of the regulation.The working group intends for the AABB/ISCT (GTP) Interpretive Tool to be a “living document” with periodic updates as new information from the FDA becomes available.