## 2 Advantages of On-Site Hospital Facilities
### Implementing GMPs in Hospitals  
While proximity provides clear advantages, implementing pharmaceutical manufacturing and GMPs within healthcare settings also poses challenges. Hospital staff are generally unfamiliar with the extensive GMP documentation, training in bioprocesses, and oversight required for clinical cell and gene therapy production [7]. Quality systems within healthcare focus on ensuring optimal medical services, whereas pharmaceutical GMPs aim to guarantee consistent product quality and safety [8]. Extensive GMP training and ongoing specialized personnel education are essential to bridge this gap. The manufacturing of autologous/allogenic ATMPs integrates key hospital units, as depicted in Figure 1, to streamline the entire production and administration process. A clinical research and clinical trials unit spearheads the development of clinical research projects, ensuring meticulous research support and data integrity. Close to this is the hematology department, which is crucial for patient management in cell-based therapies, covering diagnosis, pre-treatment assessments, and collaboration for ATMP application. Notably, the transplantation unit within this department specializes in the preparatory and follow-up care for stem cell therapy [9]. Research areas like translational research and process development bridge the gap between laboratory research and clinical application, facilitated by innovative research fields such as biomarker identification cell therapy and genetic engineering. The apheresis unit plays a vital role in the initial collection of cellular materials, ensuring expert handling of apheresis and patient care. In the sphere of product preparation, the pharmacy department is pivotal for the final formulation and storage of ATMPs, maintaining optimal conditions until clinical use. At the heart of manufacturing is the GMP facility, encompassing a comprehensive spectrum from manufacturing to quality assurance, as well as adhering to strict documentation and compliance standards. The synergy among these units, as visualized in Figure 1, is essential for the construction, qualification, validation, and maintenance of GMP facilities. This coordinated approach ensures that hospital activities, including the handling of biological samples and adherence to GMP requirements, maintain product quality throughout all manufacturing phases. Continuous communication across these units fosters an awareness of GMP regulations, which is crucial for staff members not typically versed in pharmaceutical standards [3; 10]. Quality system adaptation in hospitals, specifically focusing on product quality, safety, and efficacy, is key to implementing GMPs in hospitals. Excessive procedures solely for regulatory compliance can impede operations. A risk-based approach (RBA) in hospitals can concentrate quality efforts on critical factors affecting products and patients [8]. This method facilitates translating ATMPs to clinical practice, while ensuring compliance with pharmaceutical manufacturing standards within complex hospital environments [3; 11; 12]. This approach helps to identify priority areas where the quality system can be optimized without compromising product quality or patient safety in any case. This enables hospitals to avoid unnecessary regulatory procedures that are solely for the sake of regulatory compliance and that do not contribute to operational efficiency or patient care. This  
Figure 1: Presents a cohesive overview of the operational framework surrounding advanced therapy medicinal products (ATMPs). At the core of the illustration is the ‘ATMP’, with surrounding nodes representing various specialized units. Each hospital unit is integral to the ATMP development and application process, highlighting the collaborative nature of this advanced medicinal ecosystem. balanced approach ensures that, while regulatory standards are fully met, the primary emphasis remains on safeguarding patient health and ensuring the efficacy of ATMPs.