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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
Background
- 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:
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Date created: February 20, 2003 |
