Regulations that govern methods used in, and facilities used for manufacturing human cellular and tissue-based products. Current Good Tissue Practice (cGTP) requirements are less extensive in scope than current Good Manufacturing Practice (cGMP). cGTP requirements are limited to preventing circumstances concerning the introduction, transmission and spread of communicable disease. cGTPs are intended to assure that products do not get contaminated during manufacturing, and that product function and integrity are not impaired through improper manufacturing processes.
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture