History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
ICH Q9 QUALITY RISK MANAGEMENT
QualityQualityRisk ManagementRisk Management
ICH Q9ICH Q9
HistoryHistory
Disclaimer: This presentation includes the authors views on quality risk management theory and practice. The presentation does not represent official guidance or policy of authorities or industry.
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
ICH Q9 QUALITY RISK MANAGEMENT
Purpose of this part is to:
Guide you throughthe history of the development of the ICH Q9 document
Highlight some of the decisions and rationales for making them
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
ICH Q9 QUALITY RISK MANAGEMENT
The history of Q9 document
OsakaNovember 2003
LondonMarch 2004
WashingtonJune 2004
YokohamaNovember 2004
Draft for consultationMarch 2005
ChicagoNovember 2005
ICH Q92005
2006
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9 MilestonesNovember 2003
Osaka
March 2004London
June 2004Washington
Nov. 2004Yokohama
May 2005Brussels
2006ongoing
Sep. 2004Telecon
Nov. 2005Chicago
Feb. 2005Telecon
March 2005Steering C.
Not legally binding,unless incorporated in local law
Consensus of the 6 ICH partners and release forpubic consultation within the 3 Regions
Step 2
Scientific discussions within the EWGStep 1
Consolidation of public commentsStep 3
Agreement of the 3 ICH regulators and"Signed off" by ICH Steering Committee
Step 4
Implementation within the 3 RegionsStep 5
ICH Steering Committee agrees to new documentConcept
paper
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5
ICH Q9 QUALITY RISK MANAGEMENT
ICH Concept paper Osaka, November 2003 Technology focus
> Increase process capability
> Focus on critical control points
Product
> Stabilise manufacturing steps (decrease variability)
> Guarantee shelf-life
People
> Result in a superior performance of the Q-System
Customer
> Reduce deviation
> Reduce market complaint rate
> Reduce technical related adverse events
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 6
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Meeting London, March 2004
A draft table of contents, flow diagram, definitions were agreed
Assignments to produce first drafts of the full text for each section of the draft table of contents were agreed
Started the dialogue with the ICH Q8 EWG
Regulatory flexibility
> The degree to which the final versions of both Q9 and Q8 could refer to 'regulatory relief' was a debate on principles.
> Term changed to “regulatory flexibility” or “risk confidence”.
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 7
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9 Version 1
“Forget it”
expressed what the EWG was thinking in terms of creating text on the agreed content
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 8
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Meeting Washington, June 2004
Good agreement on overall content
> No major disagreements between parties
> Training and experience needed
The first official draft (No 2) was issued
> All accept that wording is not perfect
Reaching ICH Step 2 in November was still the target
> Highly dependent on the extent of comments received on draft
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 9
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Telecon September 2004
Optional nature of ICH Q9 to be emphasized
All EWG parties want to push ICH Q9 forward
> No support for delaying ICH Q9
Appointments for redrafting in six groups> Subgroup decide on details of Chapter 5 / 6 as annex or not> One subgroup to deal with ICH Q8 relationships
Case studies: > Which ones are appropriate to use in ICH Q8, Q9 or Q10?> Everybody should decide, whether the case studies should
be included as an annex in the ICH Q9 document or used as training material - Decision to be made in Yokohama
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 10
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Meeting November 2004
Milestone: Draft 4 issued as “pre-step 2” document
Major concerns were addressed and resolved
Primary principle: link back to the potential harm to the patient
Integration of QRM into existing systems & regulatory processes will take time
For more details:Peter Gough and Stephan Roenninger, ICH Q9 : Quality Risk Management - an update Regulatory Affairs Journal, 16, 2005, 91-93
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 11
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Telecon February, 22 2005
All EWG parties agreed to put Q9 forward to step 2
Training slides will be provided> Slides to be discussed after step 4
Next meeting of the EWG:ICH Meeting, November 2005, Chicago
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 12
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9 Expert Working Group (EWG) as of ICH Step 2
Expert WorkingGroup (EWG)
Mr. David HorowitzDirector, Office of Compliance, CDER
Dr. H. Gregg ClaycampDirector Scientific Support Staff
Ms. Diana KolaitisDistrict field inspector
Mr. Jon Edward ClarkeFDA HFD (alternate: Q8)
Dr. Greg Guyer (Rapporteur)Merck &Co, Vice President, MMD QA
Dr. Georgia KerestyCentocor, Inc.,GlobalBiologicsSupplyVice President, Worldwide Quality
Ms. Emer CookeHead of sector Inspections EMEA
Dr. Jacques MorenasInspection and Companies DirectorateAFSSAPS, FEMEA, PIC/S
Mr. David Cockburn (alternate)Principal Scientific Administrator EMEA
Mr. Peter GoughLilly, GB, Senior Quality Consultant, Corporate QS
Dr. Stephan RönningerF.Hoffmann-LaRoche, CH, Global Quality Manager
Mr. Etienne OuimetteCompliance and Enforcement Coordination division,Health prod. & Food Branch Inspectorate Health CDN
Ms. Christine MundkurInternational Generic Pharmaceutical Alliance
Mr. Frederick RazzaghiConsumer Health Product Association
Dr. Sabine KoppQA & Safety Medicines, WHO
Dr. Urs KoppHead of Inspectorate, Swissmedic
Dr. Yukio HiyamaChief, Third Section: Division of Drugs
Mr. Ichiro TsunoiCompliance & Narcotic division
Dr. Yoshihiro MatzudaMHLW, Registration Biol.
Dr. Mayumi ShikanoReview director Office of biologics
Dr. Tamiji NakanishiReviewer, Office of new drugs I
Dr. Yoshihiro MatsudaReviewer, Office of new drugs I
Mr. Takayoshi MatsumuraEisai, Assistant Manager, Corporate QA Department
Mr. Tetsuhito TakaradaMochida Pharm.Deputy Director, Quality Control
Mr. Hideo Sasaki (alternate)Nippon Shinyaka Co Ltd, Manager Anal.Chem.Sect.
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 13
ICH Q9 QUALITY RISK MANAGEMENT
Result of ICH Q9 EWG Meeting Chicago November, 6.-8. 2005
Points of discussion and changes to the step 2 document
Separate the “How to do?” (annex) from the “What to do?” (text) and move the tools examples to the annex
Modify original diagram in section 4 > Take an alternative proposal
showing communication routes
Move “continuous improvement” to Annex II.1 (see ICH Q10)
Reduce complexity by combining and re-wording the individual sections
> “formal” and “informal” risk management referenced
> “detectability” as an element in several chapters
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 14
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9 Expert Working Group (EWG) as of ICH Step 4
Expert WorkingGroup (EWG)
Dr. H. Gregg Claycamp (Rapporteur)Director Scientific Support StaffMr. A. D’SaCompliance Officer, CDERMs. Diana KolaitisDistrict field inspector
Dr. Georgia KerestyCentocor, Inc.,GlobalBiologicsSupplyVice President, Worldwide QualityMr. Tobias MassaBristol-Myers SquibbVice president Global Regulatory Sciences-CMC
Ms. Emer CookeHead of sector Inspections EMEADr. Jacques MorenasInspection and Companies DirectorateAFSSAPS, FEMEA, PIC/S
Mr. Malcolm HolmesGSK, UK, Global Quality Assurance, DirectorDr. Stephan RönningerF.Hoffmann-La Roche, CH, Global Quality Manager
Ms. Diana DowthwaiteCompliance and Enforcement Coordination division,Health prod. & Food Branch Inspectorate Health CDNMs. Christine MundkurInternational Generic Pharmaceutical AllianceMr. Frederick RazzaghiConsumer Health Product AssociationDr. Sabine KoppQA & Safety Medicines, WHODr. Markus-Peter MüllerHead of QM-Inspectorate, Swissmedic
Dr. Yukio HiyamaChief, Third Section: Division of DrugsIchiro TsunoiAssistant Director, Office of Compliance,Pharm.& Food Safety Bureau, MHLWTamiji NakanishiReviewer, Office of New Drugs I, PMDAMayumi ShikanoReview Director, Office of Biologics, PMDAYoshihiro MatsudaReviewer, Office of New Drug I, PMDAYukio SaitoGMP Inspector, PMDATakashi NagashimaGMP Expert, PMDA
Mr. Takayoshi MatsumuraEisai, Assistant Manager, Corporate QA DepartmentMr. Tetsuhito TakaradaMochida Pharm.Deputy Director, Quality ControlMr. Hideo SasakiNippon Shinyaka Co Ltd, Manager Anal.Chem.Sect.
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 15
ICH Q9 QUALITY RISK MANAGEMENT
Publication and implementation of ICH Q9
Legal position of ICH Q9
US / FDA: - Guidance for Industry (June 2006)- By law, guidance documents are not enforceable or binding FDA will use the document internally in this spirit, as well
Japan / MHLW:- Product GMP Guideline “Annex”: ICH Guidelines
EU / EMEA:EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice- EU-GMP Vol. 4, Annex 20 - Teams established to update chapters of EU-GMP, NfG etc.
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 16
ICH Q9 QUALITY RISK MANAGEMENT
European legal position of ICH Q9
Publication of the document in EU for comments:
“It should be borne in mind that this guideline does not introduce new requirements or expectations but should be considered a resource document that can be used together with existing quality-related guidelines when a risk-based approach is appropriate.”
“Therefore, as well as complementing GMP guidelines, the document should be seen as also complementing and supporting existing and future guidelines published by CHMP and CVMP concerning the quality of medicinal products.”
EU-Publication of Step 2 document
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 17
ICH Q9 QUALITY RISK MANAGEMENT
Authors Reviewers
S. Rönninger, Roche (Chair) G. Claycamp, FDA P. Gough, former Lilly M. Holmes, GSK T. Matsumura, Eisai Co. H. Sasaki, Nippon Shinyaku T. Takarada, Mochida Pharm.
E. Cooke, EMEA Y. Hiyama, MHLW D. Horowitz, FDA G. Keresty, Centocor U. Kopp, Swissmedic J. Morénas, AFSSAPS C. Mundkur, Barr Laboratories M.-P. Müller, Swissmedic F. Razzaghi, CHPA
Supported by EFPIA and JPMA ICH Q9 topic groups
ICH Q9 Briefing Pack July 2006
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 18
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9 Briefing Pack
Current direct link: http://www.ich.org/cache/html/3157-272-1.html
ICH EWG members published a set of slides with more details on possible implementations
> ICH homepage: www.ich.org -> -> scroll down to ICH Q9
On the ICH Q9 Document > Background > History > Content > Tools> Applications
Additional features > Senior Management Training > Frequently Asked Questions (Q&A)
History
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 19
ICH Q9 QUALITY RISK MANAGEMENT
Optional but can benefit
from its use!
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