OPQ Outlines New Inspection, Reporting Paradigm, Organizational Structure
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices.
The New Inspection Protocol Project, or NIPP, will eventually be incorporated into mobile technology to support investigators during inspections and while traveling, according to a white paper issued by OPQ April 15.
In addition to data obtained during inspections, product quality data produced from the FDA’s own laboratories will be used, using more sampling and testing than is required by U.S. Pharmacopeial Convention standards, OPQ says. With more testing, surveillance should predict “manufacturing outcomes, identify sources of quality variance, generate alerts when a problematic lot is produced and assess strengths of manufacturers,” the white paper says.
The white paper also provides new details on OPQ’s structure. The office is comprised of an immediate office led by CDER Director Janet Woodcock and includes administrative and science and research staff, and eight sub-offices:
- The Office of Program and Regulatory Operations, directed by Giuseppe Randazzo, is responsible for all processes associated with drug product quality reviews and facility inspections;
- The Office of Policy for Pharmaceutical Quality, headed by CDER’s former deputy director of the Office of Pharmaceutical Science, Ashley Boam, develops and implements policies, standards and guidance, including chemistry, manufacturing and controls review policy, and inspection policy and standards;
- The Office of Biotechnology Products, under Steve Kozlowski, assesses active substances, product formulations and specifications and batch data;
- The Office of New Drug Products, which will be headed by Sara Pope Miksinski, performs the same activities as OBP;
- The Office of Lifecycle Products, led by Susan Rosencrance, also assesses drug substances, formulations and specifications, this time from a lifecycle perspective;
- The Office of Process and Facilities, directed by Christine Moore, evaluates pharmaceutical manufacturing process design and controls;
- The Office of Surveillance, led by Russ Wesdyk, maintains information on all facilities involved in the manufacture of drugs destined for the U.S.; and
- The Office of Testing and Research, under Lucinda Buhse, conducts research to support development of standards and policies on pharma quality, safety and effectiveness.
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