Created with input from various global regulatory agencies, Baseline Guides are intended to establish a compliant minimum acceptable (baseline) approach to the topic area. They typically focus on the “what”.
Published: December 2023 Pages: 270 Table of Contents Special Pricing for Emerging Economies Applying emerging and digital technologies can lead to more robust and flexible manufacturing processes. This can help the pharmaceutical industry respond to
The biopharmaceutical industry has adapted to reflect available technologies such as single-use technologies and modular construction methodologies, products with more focused patient populations, evolving regulatory conditions, unrelenting pressures on costs, and increased focus on robust product supply while maintaining high-quality standards. This Guide presents concepts that reflect how these changes affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.
