FDA 21 CFR 1271 Regulations

The requirements for CGTP are found in subparts C and D of 21 CFR 1271 that govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps. This includes, but is not limited to, all the activities and tissue processing steps involved in the recovery, donor screening, donor testing, processing, storage, labeling, packaging and distribution of HCT/Ps as delineated in a guidance issued by the FDA in 2011. The 21 CFR 1271 good tissue practices for HCT/Ps function in tandem with the 21 CFR 1270 guidelines for the use of human tissues intended for transplantation.

MasterControl enables blood banks, transfusion centers, tissue banks and other organizations concerned with good tissue practices to maintain and accelerate compliance with 21 CFR Parts 1270 and 1271. The cloud-based solutions offered by MasterControl provide a secure working environment and document repository for CGTP-related documents without requiring large up-front expenses or overburdening IT departments. MasterControl’s flexibility allows HCT/P organizations to improve their existing forms according to 21 CFR Part 1271 regulations or to design new and better forms to enhance their good tissue practices. Designed to help companies replace manual paper-based processes with more efficient electronic systems, MasterControl solutions empower CGTP-minded organizations to bring compliant and safe products to market with greater efficiency.