ABSTRACT
Cellular therapy products are required to be manufactured within the Federal Drug Administration's (FDA) Code of Federal Regulations (CFR). Regulations for good tissue practice (GTP) or good manufacturing practice (GMP) defines the requirements for facilities, staffing, supplies, documentation, training, air particulate testing, gowning, and product specification testing. CFR section 351 and section 361 clarify types of products that will fall under each category of good tissue practice (GTP) versus GMP. Facilities are designed to mitigate microbial contamination and to ensure product sterility. Thorough in-process and final product testing will include sterility, purity, and potency assays to ensure product safety and efficacy.
