PDA 247.3 is a comprehensive guideline that focuses on the fundamental principles of contamination control, cleaning, and disinfection programs for aseptic manufacturing facilities. This guideline is designed to assist pharmaceutical manufacturers in maintaining high levels of cleanliness and sterility within their facilities, thereby ensuring the production of safe and effective pharmaceutical products. Key Objectives: The primary objectives of PDA 247.3 are as follows: Establishing contamination control practices: The guideline provides recommendations for implementing robust contamination control practices to prevent the introduction of microbial and particulate contaminants during manufacturing processes. This includes guidance on cleanroom design, HVAC systems, personnel training, and gowning procedures. Defining cleaning procedures: PDA 247.3 outlines the principles of effective cleaning procedures, including the selection of appropriate cleaning agents, cleaning equipment, and cleaning frequencies. It also emphasizes the importance of cleaning validation to ensure the removal of residual product and microbial contaminants. Implementing disinfection programs: The guideline highlights the significance of disinfection programs in controlling microbial contamination. It provides guidance on the selection and use of disinfectants, as well as their compatibility with different surfaces and equipment. The document also emphasizes the importance of disinfection validation and monitoring to ensure the efficacy of the disinfection processes. Establishing environmental monitoring programs: PDA 247.3 underscores the need for comprehensive environmental monitoring programs to assess the microbial and particulate cleanliness of aseptic manufacturing areas. It discusses monitoring techniques, sampling methods, and the interpretation of monitoring data, enabling manufacturers to identify potential sources of contamination and implement corrective actions.