CDER Launches Experiential Learning Program for OPQ Staff

November 18, 2016

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

In a Federal Register notice released on Nov. 16, 2016 the Center for Drug Evaluation and Research (CDER) announced it will be launching the 2017 Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. CDER said the goal of the program is to offer opportunities to staff members in the OPQ to learn about drug development and commercial lifecycle challenges facing the pharma industry. The program is expected to assist in improving the staff’s knowledge of drug manufacturing processes.

OPQ staff will observe drug manufacturing operations over a one- to two-day period. CDER is encouraging companies involved in the manufacture and development of drug substance and products to sign up to host OPQ staff at their manufacturing facility. CDER said sites will be selected for observation based on the facilities current regulatory status with FDA, the priorities of the OPQ staff training, and consultation with the appropriate FDA district office. FDA asserts this program is not intended to supplement regulatory inspection.

The OPQ staff identified several areas of interest for the training, 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

  • Biotechnology 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  

  • Three-dimensional printing

  • Nanotechnology.

For more information on how to participate in the program, review the Federal Register notice here.

Source: Federal Register