09.14.24 -- Pharmaceutical Online Best Of August

A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July.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 September 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.

PMS Senior GMP Scientist, Mark Hallworth answers questions that arose while presenting on EU GMP Guidelines for Environmental Monitoring. Explore his answers to gain insights into these guidelines.

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.

In order to maintain the highest standards of safety, sustainability, and hygiene, several crucial factors must be addressed to ensure these powders are moved without any danger to the operatives.