FDA Calls on Pharma Companies to Join Manufacturing Inspection Program

Regulatory News

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes.

The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical testing over a one- to two-day period, is designed to offer firsthand learning opportunities to improve staffers’ understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact drug development.

Focus of Inspections

OPQ has identified a number of areas of particular interest to its staff, including:

• Drug products and active pharmaceutical ingredients
• Solutions, suspensions, emulsions, and semisolids
• Sustained, modified and immediate release formulations
• Drug-device combination products, particularly inhalation, transdermal, iontophoretic, and implant formulations
• Biotech products
• Design, development, manufacturing, and controls
• Engineering controls for aseptic formulations
• Unique delivery technologies
• Hot melt extrusion processes
• Soft-gel encapsulation processes
• Lyophilization processes
• Blow-Fill-Seal and isolators
• Spray-drying processes
• Process analytical technology and real time release testing emerging technologies
• Continuous manufacturing
• 3D printing
• Nanotechnology

Selection of potential facilities for the program will be based on these priorities, FDA says, as well as the facility’s current regulatory status with FDA, and based on consultation with FDA district offices.

All travel expenses associated with this program will be the responsibility of OPQ, so selection of the sites that can participate will be based on the availability of funds and resources, and OPQ says it will not provide financial compensation to the sites as part of this program.

The program will allow participating sites to benefit by having an opportunity to showcase their technologies and manufacturing processes.

Volunteers

Companies interested in offering a site visit or learning more about this site visit program should respond by submitting a proposal to Janet Wilson at CDEROPQSiteVisits@fda.hhs.gov.

Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry