# Presentation: 656260

## ICH Quality Topics Update

- Moheb M. Nasr, Ph.D.
- Office of New Drug Quality Assessment (ONDQA), OPS, CDER
- Advisory Committee for Pharmaceutical Science (ACPS)
- October 5, 2006

## Presentation	

- Topic Introduction			Moheb Nasr, Ph.D., CDER, FDA
- Q8 – Pharmaceutical Development	John Berridge, Ph.D., Pfizer
- Q9 – Quality Risk Management		H. Gregg Claycamp, Ph.D., 						CVM, FDA
- Q10- Pharmaceutical Quality Systems	Joseph Famulare, OC, CDER, 						FDA
- Q4B – Regulatory Acceptance of	Robert H. King, Sr., CDER, FDA
- 	          Analytical Procedures and/or
-               Acceptance Criteria
- Discussion and Recommendations

## ICH Quality Topics Update

- Background Information
- A new ICH Quality Vision
- Where are we today?
- Implementation of the New Vision
- Challenges – FDA Perspective
- Future Activities
- Questions to the Advisory Committee

## ICH - Objectives

- The International Conference of Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States, in order to make these products available to patients with a minimum of delay

## ICH Process

- Step 1:	Consensus Building
- Steering Committee adopts concept paper
- Expert Working Group, rapporteured by an industry party, builds scientific consensus
- Step 2:	Confirmation of Six-Party 	Consensus
- EWG submits consensus document
- Steering Committee signs off as Step-2 final document

## ICH Process (cont’d)

- Step 3:	Regulatory Consultation and Discussion
- (a)	Regulator publishes Step-2 document for regional consultation/comments
- EU: Published as a draft CPMP guideline
- Japan: Translated and issued by MHLW for internal and external consultation
- U.S.: Published as FDA draft guidance in the Federal Register
- (b)	Discussion of regional consultation comments
- Regulator consolidates regional comments
- EWG, rapporteured by a regulatory party from the same region as Step-1, discusses regional comments and builds consensus

## ICH Process (cont’d)

- Step 4:	Adoption of an ICH Guideline
- EWG regulatory parties submit consensus document
- Steering Comm. regulatory parties sign off as Step-4 final document
- Step 5:	Regulatory Implementation
- EU: Published as CPMP guideline
- Japan: Translated and issued as guideline by MHLW
- U.S.: Published as FDA guidance in the Federal Register

## ICH Quality Topics (Prior to July 2003)

- Q1	Stability
- Q2	Validation: Analytical Procedures
- Q3	Impurities
- Q4	Pharmacopeia
- Q5	Biotech Products
- Q6	Specifications
- Q7	GMP
- M4	Common Technical Document

## ICH - A New Vision for Ensuring Product Quality (Brussels, July 2003)

- A harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to quality risk management and science
- New ICH guidelines
- Pharmaceutical Development (Q8), Quality Risk Management (Q9), and Pharmaceutical Quality Systems (Q10)
- High level guidelines, more visionary, less prescriptive, flexible regulatory approaches

## Accomplishments since July 2003

- ICH Q8
- ICH Q9
- ICH Q10 	(In progress)
- ICH Q8 (R) 	(In progress)
- ICH Q4B 	(In progress, _*not part of*_* **	**	**	**	*_*the new ICH vision*_)

## Where are we today?

- Work in Progress
- Q8(R), Q10 and Q4B
- Implementation of the new vision by industry and regulators

## FDA - Implementation of the New Vision

- Intensive efforts in the US
- Across review and inspection programs
- Several public meetings, workshops and training programs
- Withdrawal of several FDA guidances
- Development of implementation guidances (in progress)
- Quality System, PAT, Comparability Protocol, Regulatory Agreement, ..
- Restructuring of ONDC
- CMC Pilot Program
- Pharmaceutical Inspectorate (PI)
- QbR Initiative
- CDER/ORA Site Selection process for GMP inspections.
- CVM pre-approval decision support system (PAIDSS)

## Challenges in Implementation - FDA Perspective  

- Implementation Challenges
- Putting new concepts into practice (QbD, Design Space, Risk Assessment, etc.) – not easy!!
- Diversity of products
- Different regulatory processes
- Expectations for a QbD - based submissions while addressing traditional requirements (dual processes)
- Integration of review and inspection
-  Implementing while harmonizing
-  Heavy workload and limited resources

## Future FDA Activities

- ICH Meeting in Chicago, October 21-26, 2006
- PDA/ISPE Workshop, Challenges of implementing ICH Q8 & Q9, December 6 & 7, 2006 (Washington, D.C.) and  February 2007 (Brussels)
- AAPS/ISPE/FDA Pharmaceutical Quality Initiatives Workshop, February 28, 2007

## Questions

- Do you agree with FDA implementation strategy of the new ICH quality vision?
- Should FDA implement additional QRM activities, given resource constraints?
- Should FDA continue to develop additional implementation guidances or rely only on ICH guidelines?
- Is it necessary to gain experience through implementation of the new concepts prior to development of additional guidelines?