ISPE Baseline Guides

ISPE Baseline Guides are comprehensive industry resources that provide detailed standards and best practices for designing and operating pharmaceutical manufacturing facilities. They help companies ensure that facilities are built and maintained to meet quality, safety, and regulatory requirements. These guides cover various areas like cleanroom design, manufacturing processes, and utility systems, offering a structured approach to achieve consistent quality in pharmaceutical production. Essentially, they serve as a blueprint to help industry professionals develop facilities that are efficient, compliant, and capable of producing safe, high-quality medicines.