FDA ISSUANCE OF DRUG GMP WARNING LETTERS
This article was originally published in The Gold Sheet
...fell to a new low in FY 2005, with only 18 sent out worldwide. Oral solid manufacturers were not among the variety of operations targeted. A recurrent theme was inadequate contamination control, with two thirds of the letters addressing related problems. One third encompassed cGMP and NDA/monograph concerns. The warning letters provide detailed commentary on the firms’ responses to the inspection findings as well as on the FDA-483 observations themselves. As such, they shed important light on FDA compliance policy for the various types of operations addressed and on the expectations for corrective action. [The drug and therapeutic biologic cGMP warning letters issued in FY 2005 are listed. The listing is organized according to the type of facility involved, and includes the recipient’s name, letter date, plant location and a description of the problem areas cited.]
You may also be interested in...
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.