The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Considerations for Complying With 21 CFR 211.110." This draft guidance aims to help manufacturers ensure the uniformity and integrity of drug products by complying with specific regulations. It also provides insight into how advanced manufacturing techniques, like 3D printing and continuous manufacturing, can be incorporated into manufacturing processes. The FDA encourages industry representatives who are interested in using innovative control strategies to contact them for further guidance.
Simple Explanation
The FDA is sharing advice on how to make sure that medicines are made the same way every time and are safe to use, even with new methods like 3D printing. They want companies to talk to them if they have new ideas for how to control their manufacturing processes better.