# Presentation: 252035

## Update on Compliance CGMP Initiatives
DIA Annual Meeting
June 29, 2005

Joseph C. Famulare
Director, Division of Manufacturing and Product Quality
Office of Compliance, CDER

**DIA Annual Meeting**
**June 29, 2005**
**Joseph C. Famulare**
- Director, Division of Manufacturing and Product Quality
- Office of Compliance, CDER

## Goals and Objectives

- Where have we been over the last two years:
*Pharmaceutical CGMPs for the 21**st** Century – A Risk Based Approach*
*August 2002: ***http://www.fda.gov/oc/guidance/gmp.html**

## Initial Plan

- The most up-to-date concepts of risk-management and quality systems approaches are incorporated while continuing to ensure product quality
- The latest scientific advances in pharmaceutical manufacturing and technology are encouraged
- The submission review program and the inspection program operate in a coordinated and synergistic manner

## Initial Plan

- Regulation and manufacturing standards are applied consistently
**Management of the program encourages innovation in the pharmaceutical manufacturing sector**
- FDA resources are used most effectively and efficiently to address the most significant health risks

## Initial Plan

*Integrated quality systems orientation –                  ...***interaction of the pre-market CMC review process and the application of CGMP requirements will be evaluated as an integrated system**
*International cooperation* – **The globalization of pharmaceutical manufacturing requires a global approach to regulation.  FDA will collaborate with other regulatory authorities, via ICH and other venues**

## Risk Based Approach – Key Areas

**Why Now ?**

- Recalls

- Consent Decrees

- International Harmonization

**CONTINUOUS **
**IMPROVEMENT**

- Quality by Design

- Quality Management

## Progress on the    Pharmaceutical Inspectorate

- Where we started:
- Part of the Quality Drug Initiative
- Summer 2002 initiated discussions
- Dedicated investigators
- Initiated training for Process Analytical Technology

## Progress on the    Pharmaceutical Inspectorate

- Derived Goal
- The ability to implement the desired state
- Close working relationship between Counter-Parts in the field and the centers
- Office of Compliance
- Review Divisions

## Progress on the    Pharmaceutical Inspectorate

- How is this being developed
- Initiated Level II Certification for the drug program
- Expanded the Field Certification Program to a new level

## Progress on the    Pharmaceutical Inspectorate

- Certification Program
- Curriculum Defined
- Formal National Courses, Web based training, OJT, District Courses
- Assessments
- Certification Board
- Continuing Education

## Progress on the    Pharmaceutical Inspectorate

- Status of Program
- PAT team training
- Level II Certifications
- Auditors
- Level III (PI) Candidates
- Curriculum Development

## Progress on the    Pharmaceutical Inspectorate

- Training Modules
- Regulating Pharmaceutical Quality and Relationship to FDA’s Mission
- Risk Management
- Advanced Quality Systems
- Pharmaceutical Science
- Current Regulatory Programs and Procedures
- Technology
- Investigational

## Progress on the    Pharmaceutical Inspectorate

- Regulating Pharmaceutical Quality and Relationship to FDA’s Mission
- Philosophy
- Risk Management
- Current Concepts relating to product quality
- How to apply knowledge to inspections
- GMP compliance vs. state of control
- Impact of GMP violations

## Progress on the    Pharmaceutical Inspectorate

- Advanced Quality Systems
- Quality management techniques
- Implementation of quality system approaches to pharmaceutical production
- Pharmaceutical Science
- Science underlying approached to controlling product quality
- Causes of variability

## Progress on the    Pharmaceutical Inspectorate

- Current Regulatory Programs and Procedures
- Integration of review and inspectional programs regarding product quality
- Critical thinking
- Inspectional discretion
- Effective communication of complex issues

## Progress on the    Pharmaceutical Inspectorate

- Technology
- Science and technology advances in pharmaceutical manufacturing
- How advances enhance quality of inspections
- Impact on inspectional approach
- Best practices
- Future technological developments

## Progress on the    Pharmaceutical Inspectorate

- Investigational
- Identifying new knowledge needed
- Sources of Information
- Investigational differences across program areas

## Progress on the    Pharmaceutical Inspectorate

- Next Steps
- Finish modules
- Details to Headquarters
- Board review and Certification at       Level III

## Progress on the    Pharmaceutical Inspectorate

- Results
- Well trained workforce
- Mechanism to train on new technologies
- Closer interactions between Centers and ORA
- Consistency
- Roll-out policy changes
- Credit to Susan Setterberg / RFDD / PHI-DO

## PreApproval Inspection Program Updates

- To date – Mandatory Inspection Triggers have been eliminated
- e.g. new chemical entity
- Preapproval Inspections are impacted by Quality System Inspections
- All profile classes covered
- Need to address and operationalize new concepts
- Knowledge transfer
- Design transfer
- Integration of review and inspection

## PreApproval Inspection Program Updates – Conclusion(s)

- We have been through the exploratory stage in the CGMP for the 21st Century Initiative

## PreApproval Inspection Program Updates – Conclusion(s)

- Can Industry Take Advantage of these ideas and put them into operation
- Can FDA Respond with the Appropriate Regulatory Structure
- Highly Trained Investigators
- Use of Science
- Less Need for Supplements
- Fewer More Focused Inspections Based on Risk