Drugs

CDER Inspection Site Selection Model MAPP

CDER has issued a Manual of Policies and Procedures for the site selection model (SSM) used by Center staff to prioritize manufacturing sites for routine CGMP surveillance inspections. The document says the Center implemented a risk-based approach to prioritizing human drug manufacturing sites for routine CGMP surveillance inspection in 2005.

The MAPP says the Office of Surveillance in the Office of Pharmaceutical Quality is responsible for producing CDER’s site surveillance inspection list that prioritizes sites for surveillance inspections. The list is developed, it says, by inputting sites from the Center’s Catalog of Manufacturing Sites into the site surveillance model. The SSM ranks subject sites so that the highest risk sites are assigned to the Office of Regulatory Affairs for surveillance inspection.

In a statement on FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities, commissioner Scott Gottlieb pointed to the MAPP as one of several efforts the agency has taken. “We’ve established a framework to help assure that drug products all meet the same high-quality standards, regardless of where they’re manufactured, and whether they’re brand name or generic products, or prescription or over-the-counter drugs,” he says.

In addition to the MAPP, Gottlieb references use of a mutual recognition agreement to recognize drug inspections conducted by foreign regulatory authorities that meet U.S. requirements, modernization of the agency field organization structure, guidance documents on quality issues, and updating of the inspections classification database. He also says FDA has enhanced communications about inspections to facility owners to enable quicker resolution of situations where quality standards are not being met.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome