Notice Number: NOT-FD-18-007

Key Dates
Release Date: March 13, 2018

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

FDA's PAR Notice - Enhancing Regulatory Science for the Risk Based Assessment of Emerging Manufacturing Program has made updates to its section on page 5 titled " Project Objectives". The updates are highlighted below

Project Objectives
The goal of this program is to support the advancement of regulatory science that can facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector. Emerging manufacturing technology can be defined as a technology that has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable, or cost-effective processes and with which the FDA has limited review or inspection experiences due to the relative novelty of the technology. Examples of such elements include an innovative or novel: (1) product manufacturing technology, such as the dosage form; (2) manufacturing process (e.g., design, scale-up, and/or commercial scale); and/or (3) testing technology.
Identified emerging technologies should be sufficiently developed and likely ready for industrial implementation for the purpose of product quality enhancement. The results and knowledge developed in this program can be utilized by industry, academia, and industry to support the implementation of the identified emerging technologies and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science. Specifically, the expected project outcomes should enable (1) developing tools and approaches for risk-based quality assessment, (2) establishing science-based quality standards and policies, and/or (3) providing training tools for both the industry and/or the regulatory bodies for the identified emerging technology.
As an example, one such emerging manufacturing technology that offers potential flexibility, quality, and economic advantages over traditional processing methods is continuous pharmaceutical manufacturing. Potential research projects to support the implementation of continuous manufacturing may include:
1. Development of approaches to capture the properties and behavior of common raw materials within different continuous process environments to facilitate initial risk screening during quality assessment.
2. Development of process modeling and simulation or pharmaceutical quality informatics platforms that can support risk-based quality assessments
3. Development of science and risk based approaches for the effective regulatory assessment of advanced process control approaches to evaluate the performance, for example, to determine the adequate amount of information needed to validate the performance of advanced process control systems for pharmaceutical applications.  
4. Development of a general approach for supporting real time release testing (RTRT). The science and risk based approach should facilitate determination of how much and what type of information and data analysis would be needed to support RTRT.
5. Development of tools and approaches for the risk-based quality assessment for new manufacturing technologies that enable continuous homogenous processing. Examples of such homogeneous processes include extrusion, spray drying, thin film formation, electrospraying and electrospinning, and injection molding and calendaring.

"Another good example can be regulatory science research projects focusing on characterizing complex drug substances and complex drug product dosage forms, and/or related control strategies to ensure the product quality, especially those which can help solve potential regulatory questions related to drug quality. Some specific areas of research could include the following, but proposals should clearly describe the potential impacts of the proposed technology on readiness for broad implementation in pharmaceutical industry, control strategy, and/or regulatory evaluation for complex drug substances and complex drug product dosage forms:
1. Appropriate analytical methods for complex drug substances or products
2. In-process controls during manufacturing processes to ensure product quality
3. Raw material quality control"

Inquiries

Please direct all inquiries to:

Kathryn Hughes, Ph.D.
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Telephone: 301-796-4582
Email: kathryn.hughes@fda.hhs.gov