IPQ’s coverage during October provided an exploration of how FDA’s quality regulatory operations are being transformed to: ● more coherently assess a company’s quality management abilities ● understand better where the patient risks and protections lie within particular operations and across the global manufacturing and supply chain spectrum, and ● be more effective in using its regulatory suasion to help industry evolve from a compliance to a quality culture-oriented mindset.
The first story in our Monthly Update for October explores the closer alignment that is underway between the centers and the field inspection operations under the leadership of Commissioner Hamburg and CDER Director Woodcock to help bring the new regulatory paradigm to life. The second story delves deeper into the role CDER’s new Office of Pharmaceutical Quality will play in driving forward the various significant initiatives that are now in motion.
On the international front, two important and related ICH guidelines have reached final form – on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7). The IPQ stories include insights from key members of the Expert Working Groups that put the guidelines together on their development and the challenges that industry and regulators now face in implementing them.
In addition to the normal array of briefs, the IPQ Monthly Update for October contains a significant new feature – a listing of all drug GMP warning letters and recalls posted by FDA during the month.
The key concerns that each of the warning letters address and links to the letters themselves are provided. Included are notes on salient features of the warning letter with links to IPQ’s related coverage.
The recall compilation includes the generic names of the products, the dosage form, the manufacturer, the number of lots involved, FDA’s classification, and the specific reason provided by the agency. The recalls are grouped by the general category of problem that caused them. Links are provided to the full enforcement report listing for each of them.
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