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U.S. Department of Health and Human Services


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"A Drug Quality System for the 21st Century" Workshop

Cosponsored by the Product Quality Research Institute and the Food and Drug Administration

Comments on this report or on the activities of this working group should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059.

Workshop Final Agenda [PDF ]    Breakout Sessions    Workshop Summary


  • This initiative is intended to step back and evaluate the currency of FDA drug product quality regulatory system (CMC review and cGMP inspections) to ensure that:
  • the most up-to-date concepts of risk management and quality systems approaches are incorporated;
· the latest scientific advances in pharmaceutical manufacturing and technology are utilized;
· the submission review program and the inspection program operate in a coordinated and synergistic manner;
· regulation and manufacturing standards are applied consistently;
· management of the program encourages and does not impede innovation in the pharmaceutical manufacturing sector; and
· resources are used most efficiently to address the most significant health risks.
  • On 20 February 2003 FDA provided information on the progress made on the immediate steps outlined in the 21 August 2002 announcement. This information is available in a Summary Progress Report.
  • This workshop is your opportunity to share with FDA your perspectives and ideas on FDA's current thinking as outlined in the announcement on 20 February 2003 and further explained in presentations at this workshop.
  • This is the inaugural workshop and it is intended to seek your input on certain key elements of the initiative. Information on topics of significant interest not covered in this workshop will be provided and subsequent workshops will be developed for in-depth discussion on these topics.
  • This workshop utilizes break-out discussion sessions to ensure a very interactive format for you to participate and contribute to the evolution of this initiative. It is therefore important that you review the information provided by FDA on 20 February 2003, available at http://www.fda.gov/cder/gmp/index.htm.
  • If you wish to share your perspectives and ideas with FDA and the workshop participants prior to this workshop please submit these in writing to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059.
  • Note that the title of this workshop "A Drug Quality System for the 21st Century" is intended to signify that this is a broad initiative that covers both the cGMP inspection and CMC review processes.

Workshop Goals and Objectives

The Workshop is designed to:

  • Provide an overview of FDA activities and current thinking;
  • Provide an opportunity for in-depth discussion on four topic areas, namely:

1) Risk-Based cGMP’s: Defining Risk & Quality
Definition of risk and quality; science based approaches to risk classification; risk in relation to intended use (safety & efficacy); risk and cGMPs; risk identification and mitigation strategies.

2) Integrated Quality System
Identify and discuss the need for an integrated approach to the review and inspection process; approaches for improving consistency (between different Centers and between Center and Field) of regulatory decisions; value, and optimal use of product specialists on inspection teams; risk-based approach to inspections; and training of pharmaceutical inspectorate.

3) Changes without Prior Approval
Discuss scientific risk-based approaches for identifying low risk manufacturing changes that can be implemented without prior FDA approval; draft guidance on comparability protocol for small molecules; development of comparability protocol for proteins/large molecules; effective use of development data and other information to justify less burdensome filing requirements of post-approval manufacturing changes ("Make Your Own SUPAC" concept).

4) Manufacturing Science
Discuss the current, and define a desired state of pharmaceutical manufacturing science and associated regulatory processes; science of product/process development and process validation; quality by design and risk mitigation via process controls; approaches introduction of new technologies and continuous improvement; FDA's PAT Initiative and its role in the cGMP Initiative (http://www.fda.gov/cder/OPS/PAT.htm); and science-based approach to technical issues resolution.

  • Develop a workshop report summarizing stakeholder perspectives and suggestions on the FDA initiative and current thinking


 Workshop Final Agenda [PDF ]

 Breakout Sessions: