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ICH Quality Systems Why

The document discusses the proposed ICH Q10 guideline, which aims to harmonize quality systems across regions and facilitate implementation of continuous improvement throughout the product lifecycle. It proposes that Q10 define modern quality systems needed to ensure quality, serve as a bridge between regional regulations, and utilize existing quality system documents. The potential benefits include harmonized quality systems, enabling benefits of other ICH guidelines, encouraging improved processes, and demonstrating commitment to innovation and patient access. It provides a timeline showing the working group developing Q10 with the goal of a Step 2 draft by Spring 2007.

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141 views14 pages

ICH Quality Systems Why

The document discusses the proposed ICH Q10 guideline, which aims to harmonize quality systems across regions and facilitate implementation of continuous improvement throughout the product lifecycle. It proposes that Q10 define modern quality systems needed to ensure quality, serve as a bridge between regional regulations, and utilize existing quality system documents. The potential benefits include harmonized quality systems, enabling benefits of other ICH guidelines, encouraging improved processes, and demonstrating commitment to innovation and patient access. It provides a timeline showing the working group developing Q10 with the goal of a Step 2 draft by Spring 2007.

Uploaded by

Narendrakumar
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© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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ICH Quality Systems

(AKA Q10)

Gerry Migliaccio
Pfizer Inc

AAPS Workshop – Pharmaceutical Quality Assessment


October 6, 2005
Discussion Topics

„ Informal Working Group Members


„ ICH Quality Systems
‰ Proposal for a Q10 document
‰ Why Q10?
‰ Proposed Structure
‰ Potential Benefits
‰ Business Case for Q10
„ Timeline
„ Q&A
Quality Systems Informal Working
Group
„ EU „ EFPIA
‰ Mr. Jacques Morénas ‰ Dr. Gerd Fischer
‰ Mr. Jean-Louis Robert ‰ Mr. Neil Wilkinson
‰ Mr. Ian Thrussel

„ FDA „ PhRMA
‰ Ms. Diana Amador ‰ Dr. Barbara Allen
‰ Mr. Joe Famulare ‰ Mr. Gerry Migliaccio
‰ Dr. Chris Joneckis

„ MHLW „ JPMA
‰ Dr. Yukio Hiyama ‰ Dr. Takemine Kanai
‰ Dr. Yoshihiro Matsuda ‰ Mr. Makoto Shigemitsu
‰ Mr. Takashi Nagashima ‰ Mr. Tetsu Yamada
‰ Mr. Yoshihiko Yanagihara
Observers and Interested Parties

„ Observers
‰ Mr. Sultan Ghani – Health Canada
‰ Dr. Sabine Kopp – WHO
‰ Dr. Markus-Peter Müller – Swissmedic

„ Interested Parties
‰ Dr. Petar Vojvodic – Boots Healthcare Int.
‰ Dr. Joannes Moors – Pharmachemie BV
Q10 Proposal
„ Q10 will not be a global GMP guideline!
„ Q10 will:
‰ Define the modern quality systems needed to assure
quality over the lifecycle of the product.
‰ Serve as a bridge between different regional
regulations leading to a harmonized position on quality
systems.
‰ Use existing Quality Systems Documents such as ISO
and the draft FDA guidance.
‰ Facilitate realization of full benefits of ICH Q8
(Pharmaceutical Development) and Q9 (Quality Risk
Management).
Q10 Proposal

„ Scope to include drug substance and drug


product.
„ ISO terminology, structure and concepts will be
used - a pharmaceutical context for the terms
and elements will be developed.
„ Life cycle focus – starting in Development,
during Technology Transfer and throughout
Commercial Manufacture.
Why Do We Need Q10?

„ Divergent approaches to quality systems


across regions.
‰ Suboptimal deployment of resources by both
industry and regulators.
‰ Potential impact on availability of medicines.
‰ Potential delays in the implementation of
innovation and continuous improvement.
‰ Potential delays in new product launches.
‰ Inconsistent approaches to compliance
inspections.
Proposed Q10 Structure

„ Terminology
„ Quality Management System
„ Product Realization
„ Measurement, Analysis and Improvement
Q10 Potential Benefits
„ Harmonize the concept of quality systems for
pharmaceutical industry between the three regions.
„ Enable the potential benefits from ICH Q8, ICH Q6A
and ICH Q9 to be fully realized.
„ Encourage industry to improve manufacturing
processes thus reducing undesired variability and
leading to a more consistent product quality,
improved process robustness and more efficient
processes.
„ Demonstrate industry and regulatory commitment
to robust quality systems and technical innovation
and enhance assurance of consistent availability of
medicines around the world.
Q10 Potential Benefits
„ Facilitate innovation and continual improvement as
defined in this guideline throughout the whole
product life cycle.
„ Provide the link between development and
manufacturing to ensure systems are in place to
ensure and to give confidence that the correct
decisions are made by industry to manage changes,
both within and outside the design space.
„ Facilitate management commitment to quality.
„ Encourage a science and risk based approach to
quality decisions.
Q10 Potential Benefits

„ Encourage a preventive action culture, which


ensures actions are taken before a problem/issue
arises.
„ Improve quality monitoring and review (e.g. data
evaluation, statistical process control and process
capability measurements), which form the basis for
continual improvement of processes.
„ Provide greater assurance there is no unintended
consequence as a result of continual improvement
activities.
Q10 Business Case

„ Cost Savings
‰ Improved process performance
‰ Reduce cost of internal failures
‰ Reduce cost of delayed implementation of improvements
‰ Reduce cost of preparing and reviewing post-approval
submissions
„ Potential Savings
‰ Global data is difficult to obtain
‰ IBM Business Study (May 2005) estimates potential 3%
COGS savings related to internal failures
„ Cost to Implement
‰ Dependent on current state of quality system in firm along
with size and complexity
“Q10” Timeline

„ September 9th – Draft Concept Paper and


Business Case submitted to ICH Steering
Committee
„ September 21st – Quality Systems proposed as
new topic to ICH Steering Committee
„ November 7th – Commence work plan at ICH
meeting in Chicago
„ Spring 2007 – Step 2 Q10 document available
Questions?

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