The Quality System (QS) Train is Moving Fast at FDA

Lana L. Pauls, MPHDirector, Quality Management Staff

CDER/FDA

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Learning Objectives At the conclusion of this session, participants should be able to: 1. Summarize the basic concepts of a quality

system2. Describe the basic areas that FDA is

implementing a QS3. Discuss the detailed progress that FDA has

made in regard to using a QS in three specific areas:

1. CBER2. CDER/CBER - QMS for CMC3. CDER - QMS impact on drug safety

What is a Quality System?

• In a nutshell . . .– Say what you do– Do what you say– Prove it– Improve it

Why a QS?

• Helps organize workflow

• Helps prioritize resources

• Minimizes employee frustration

• Minimizes Industry frustration

• Has been expected of Industry for many years

• It just makes sense!

Why Now?

• PDUFA 3 Mandate

• In the FDA strategic plan

What Has Happened?

• QS Framework developed in 2004– SMG 2020 being used broadly across FDA (albeit

slowly)

• FDA Quality Resource and Guidance Team (QRGT)– Agency-level group of quality experts that provides:

• resource materials and guidance • recommendations to the Management Council • Agency-wide implementation plans and communications

Scope of QS Implementation at FDA (1)

1. Regulatory laboratory accreditation

2. CGMP initiative:a. Recalls of pharmaceutical product

b. Warning letters related to CGMP issues

c. FDA pharmaceutical inspectorate

d. Process analytical technology (PAT) team

e. Team Biologics quality program

Scope of QS Implementation at FDA (2)

3. Innovations in medicine:a. Pre-approval review

b. Bioresearch monitoring (BIMO)

4. FDA Office of Managementa. IT Enterprise Architecture

b. PDUFA III Business/IT Governance

PDUFA 3 QS Contracts

• PDUFA 3 set aside for “Performance Excellence”

– Nine contracts awarded to date1. Postmarketing Commitments2. Meeting Minutes3. OND Process Improvement4. OCPB Process Improvement5. Quality System for CMC6. OSE Process Improvement7. Managerial costing (completed)8. Evaluation of DSOB9. Quality system training (completed)

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Presenters

Deborah Jansen– “What Do You Mean When You Say Quality

System: A CBER Perspective”

Jon Clark

Lana Pauls– “QMS: The Impact on the Drug Safety

Process”