ABSTRACT
This chapter delves into current Good Manufacturing Practices (cGMP) expectations for combination products, and more specifically reviews the US FDA cGMP expectations under 21 CFR Part 4. The “Streamlined Approach” to demonstrating compliance is reviewed, including case studies. While this regulation is US-based, it is a risk-based approach that may be helpful conceptually to ensure sound manufacturing controls that can help inform cGMP best practices outside the United States, too. The chapter also reviews the impactful expectations (and still evolving understanding) of combination products under EU MDR (2017/745) and cGMPs for “combination products” in the United Kingdom post-Brexit.
