In case of advanced medicinal products of biological origin, the GMP requirements are adjusted to the products’ special demands, especially in the U.S. and in the EU. These products are defined in the U.S. as “of biological origin” and in Europe as “Advanced Therapy Medicinal Products” (ATMP). These products are mostly applied in special individualized therapies. In contrast to the classical pharmaceutical industry, alternative manufacturing and quality control approaches are allowed, if the modifications follow the risk-based approach, are traceable and guarantee quality, safety, and efficacy of the product. Therefore, special instructions and requirements have been added to the guidelines.