09.14.24 -- Outsourced Pharma Best Of August

This CMC (chemistry, manufacturing and control) professional spends a good deal of time thinking about and interacting with his CDMOs. Through his experience, he knows that ineluctably some form of challenge will arise. Just another day at the office?

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

The pharmaceutical industry is undergoing a transformative shift from batch to continuous flow processes, enabling enhanced efficiency and safety as well as improved sustainability.

Learn why adherence to sterile conditions is an essential step in drug development and manufacturing to guarantee the safety, efficacy, quality, and regulatory compliance of pharmaceutical products.

Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.