[Quality Dialogue] FDA's Drug Quality Supervision

No matter how good the idea, no matter how capable leadership is, they are powerless in the face of an expanding bureaucracy.

Robinia: What's so good about the article?

Editor: First of all, the article presents facts, is reasonable and scientific, and the text is concise, easy to understand, and meaningful.

Robinia pseudoacacia: Perhaps because of the training and experience of being a doctor, she knows how to communicate with people.

Editor: The more important thing is the idea of ​​the article, which contains many concepts that people often mentioned or used later, such as: drug shortage is a quality attribute, clinically relevant quality attributes, statistical sampling, release testing and process testing, quality comes from Design and scientific knowledge of products and processes, dissolution, bioequivalence and in vitro and in vivo correlation, risk-based quality management, etc.

Robinia: Although some concepts were first put forward by others, in her article, these concepts are integrated organically and naturally, which broadens people's horizons on the concept of drug quality and inspires people to further think about the concept of drug quality .

But have you noticed that some of the concepts she put forward were not implemented satisfactorily?

Edit: Really? Haven't these concepts been mentioned all the time, not only by the FDA, but also by the world, including my country.

Robinia pseudoacacia: mention it, mention it, do it.

Editor: Isn't Woodcock the person in charge of the FDA's drug regulation? What she advocates is scientifically reasonable.

Robinia: Take risk-based GMP supervision as an example.

Edit: Is there such a thing? !

Robinia pseudoacacia: Perhaps the more tragic thing is the experience of drug quality measurement.

Editor: Culture is way of life.

Robinia: Exactly.

Editor: After reading Woodcock's article, I was originally very excited, but after you say so, I feel a little sad.