Scribd
Upload
563 views

Implementation of ICHQ8 Q9 & Q10 Guidelines

The document discusses the ICH Q8, Q9, and Q10 guidelines for pharmaceutical quality. It provides background on the ICH harmonization process and the status of each guideline. ICH Q8 introduced the concept of design space and regulatory flexibility for post-approval changes. ICH Q9 provides principles and tools for quality risk management. ICH Q10 focuses on complementing Q8 and Q9 and bridging regional regulations through pharmaceutical quality systems.

Uploaded by

Narendrakumar
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF or read online on Scribd
563 views

Implementation of ICHQ8 Q9 & Q10 Guidelines

The document discusses the ICH Q8, Q9, and Q10 guidelines for pharmaceutical quality. It provides background on the ICH harmonization process and the status of each guideline. ICH Q8 introduced the concept of design space and regulatory flexibility for post-approval changes. ICH Q9 provides principles and tools for quality risk management. ICH Q10 focuses on complementing Q8 and Q9 and bridging regional regulations through pharmaceutical quality systems.

Uploaded by

Narendrakumar
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF or read online on Scribd
You are on page 1/ 6

Implementation of ICH Q8,

Q9, and Q10 Guidelines

FDA/Industry Panel Discussion


2006 GPHA Fall Technical Conference
Nicholas Cappuccino, Ph.D.
Andrx Pharmaceuticals
Agenda
n The ICH process
n History and status of the Guidelines
n Nuts and bolts of the Guidelines
n Status in US Drug Regulation
The ICH Process
n A ‘harmonization’ Process
n 3 Regions: US, EU, and Japan
n Six Parties
n 5 step Guideline Process
n ICH Q8, Q9, Q10 and FDA’s Pharmaceutical CGMPs
for the 21st Century
n Q8, Q9, and Q10 are different from other ICH
guidelines in that they are more philosophical than
procedural
ICH Q8 Pharmaceutical Development

n Accepted as an ICH topic in September 2003


n Provides guidance on Section 3.2.P.2 of the Common
Technical Document
n Reached Step 5 in November 2005
n Published in Federal Register Volume 71, No. 98 on
May 22, 2006
n Introduced concept of “design space” and “regulatory
flexibility” for post-approval changes
n Question-Based Review Initiative by OGD
n Q8(R1) under development by ICH EWG
ICH Q9 Quality Risk Management

n Accepted as an ICH topic in September 2003


n Provides principles and examples of tools of quality
risk management that can be applied to all aspects of
pharmaceutical quality
n Reached Step 5 at ICH in November 2005
n Published in Federal Register Volume 71, No. 106 on
June 2, 2006
n Q9 Briefing Pack available at ICH website,
www.ich.org
ICH Q10 Pharmaceutical Quality
Systems
n Formally accepted as an ICH topic in September 2005
after 2 years of “informal” discussions among quality
experts at formal ICH meetings
n Focus is to complement and facilitate the
implementation of Q8 and Q9 and a bridge among
different regional regulations
n ICH Step 1 document under discussion at ICH
meeting in Chicago next week
n Projected to reach ICH Step 2 in spring/summer 2007
n FDA September 2006 Guidance: Quality Systems
Approach to Pharmaceutical CGMP Regulations

You might also like