The Center for Drug Evaluation and Research (CDER) in the US Food and Drug Administration (FDA) has announced the formation of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The program is intended to provide FDA staff with a better understanding of drug-development and manufacturing processes through site visits of pharmaceutical companies.
In this site visit program, groups of OPQ staff with experienced backgrounds in science, statistics, manufacturing, engineering, and testing will observe operations of commercial manufacturing, pilot plants, and testing over a one to two-day period. To facilitate the learning process for OPQ staff, overview presentations by industry members related to drug development and manufacturing may be provided, which may allow the participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes.
OPQ is encouraging companies engaging in the development and manufacturing of both drug substances and drug products to respond, including for specialized areas, such as continuous manufacturing, process analytical technology, real-time testing, 3-dimensional printing, and nanotechnology. This site visit program is not intended to supplement or to replace a regulatory inspection, however.
Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility’s current regulatory status with FDA, and on consultation with the appropriate FDA district office. OPQ will not provide financial compensation to the pharmaceutical site as part of this program. Pharmaceutical companies interested in partifcipating should submit either an electronic or written site visit proposal to CDER’s OPQ by January 17, 2017.
The CDER initiated this program, in addition to various training and development programs, to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations as well as of the challenges that impact a drug’s development program and commercial lifecycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry.