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
Mr. Jacques Morénas Mr. Jean-Louis Robert Mr. Ian Thrussel

Dr. Gerd Fischer Mr. Neil Wilkinson

Ms. Diana Amador Mr. Joe Famulare Dr. Chris Joneckis

Dr. Barbara Allen Mr. Gerry Migliaccio

Dr. Yukio Hiyama Dr. Yoshihiro Matsuda Mr. Takashi Nagashima Mr. Yoshihiko Yanagihara

Dr. Takemine Kanai Mr. Makoto Shigemitsu Mr. Tetsu Yamada

Observers and Interested Parties
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


Sign up to vote on this title
UsefulNot useful