Validation

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.

CDER published its yearly Guidance Agenda today giving the industry a look at what to expect for the coming year in terms of issuance of documents. This yearly exercise, while not guaranteeing that all of the guidance will actually be completed, provides a nice look into the important topics that CDER is planning to expound upon for the benefit of transparency.