Ich Quality Systems Why
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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
Mr. Jacques Morénas Mr. Jean-Louis Robert Mr. Ian Thrussel
FDA
Dr. Yukio Hiyama Dr. Yoshihiro Matsuda Mr. Takashi Nagashima Mr. Yoshihiko Yanagihara
EFPIA
Ms. Diana Amador Mr. Joe Famulare Dr. Chris Joneckis
MHLW
PhRMA
Dr. Gerd Fischer Mr. Neil Wilkinson
Dr. Barbara Allen Mr. Gerry Migliaccio
JPMA
Dr. Takemine Kanai Mr. Makoto Shigemitsu Mr. Tetsu Yamada
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
Potential 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 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?
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
Mr. Jacques Morénas Mr. Jean-Louis Robert Mr. Ian Thrussel
FDA
Dr. Yukio Hiyama Dr. Yoshihiro Matsuda Mr. Takashi Nagashima Mr. Yoshihiko Yanagihara
EFPIA
Ms. Diana Amador Mr. Joe Famulare Dr. Chris Joneckis
MHLW
PhRMA
Dr. Gerd Fischer Mr. Neil Wilkinson
Dr. Barbara Allen Mr. Gerry Migliaccio
JPMA
Dr. Takemine Kanai Mr. Makoto Shigemitsu Mr. Tetsu Yamada
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
Potential 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 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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