IPQ Monthly Update — November 2014 in Review

In its October Monthly Update, IPQ explored how FDA is transforming the structure and function of its pharmaceutical quality operations to help evolve the regulatory paradigm, and the significant impact those efforts will have on industry and the way it interacts with the agency across the review and inspection spectrum.

The Monthly Update for November delves deeper into the infrastructure of CDER’s new Office of Pharmaceutical Quality.  In focus are two of OPQ’s offices that will be on the front line of the industry/agency interactions: ● the Office of Program and Regulatory Operations (OPRO), which will play a pivotal role in CMC reviews for both NDAs and ANDAs, and ● the Office of Surveillance, which will be spearheading the agency’s effort to more coherently assess a company’s quality management abilities and retool its inspection operations accordingly.

The two stories offer insights from the incoming management of the offices on how they are taking shape, their purview, their mission, their impact, and the initiatives that they will be driving as OPQ’s operations get underway in January.

The opening story in the international section of the November Monthly explores a significant initiative underway by the Europe-based Active Pharmaceutical Ingredients Council (APIC) to map out the API registration requirements in emerging countries, define best practices, and develop strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes.

The following story describes the effort spearheaded by the International Pharmaceutical Excipients Council of the Americas to develop an IPEC “Technically Unavoidable Particle Profile” (TUPP) guide designed to improve excipient maker/user communications on the visible particles. With the help of insights from the leader of the IPEC effort, the story provides an analysis of the communication problem, which has the potential for leading to unnecessary batch rejections and inspection concerns, and how the guide will help address it.

In addition to the normal array of briefs with links to the relevant documents and IPQ in-depth coverage, the IPQ Monthly Update for November continues a new feature that began in October – 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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To access the Monthly Update, subscribers please, click here.