ICH Publishes Questions-and-Answers Document on Q8, Q9 and Q10

The Quality Implementation Working Group on Q8, Q9 and Q10 published a first Questions-and-Answers document. In order to facilitate the implementation of the Q8/Q9/Q10 guidelines, the ICH Experts have developed a series of Q&As. This document was finalised on March 11, 2009 and approved by the ICH Steering Committee under Step 4 on April 15, 2009.

The document contains answers to frequently asked questions on the following subjects:

  • Quality by Design (Design Space, Real-Time Release Testing, Control Strategy)
  • Pharmaceutical Quality System
  • New ICH Guidelines`impact on GMP inspection practices
  • Knowledge Management
  • Software Solutions

It is the objective of ICH to help industry and authority in the implementation of the new quality paradigm introduced with the 3 "Q-Guidelines". Below you will find two interesting Q&As related to the impact of the new ICH Q8, Q9 and Q10 Guidelines on GMP inspection practices in the document:

How will product-related inspections differ in an ICH Q8, Q9 and Q10 environment?

In the case of product-related inspection (in particular pre-authorisation) depending on the complexity of the product and/or process, there could be a need for greater collaboration between inspectors and assessors for example for the assessment of development data. The inspection would normally occur at the proposed commercial manufacturing site and there is likely to be greater focus on enhanced process understanding and understanding relationships e.g., Critical Quality Attribute (CQAs), Critical Process Parameters (CPPs). It will also extend into the application and implementation of quality risk management principles, as supported by the Pharmaceutical Quality System (PQS).

How will system-related inspections differ in an ICH Q8, Q9 and Q10 environment?

The inspection process will remain similar. However upon the implementation of ICH Q8, Q9 and Q10, inspections will have greater focus (but not only) on how the PQS facilitates the use of e.g., Quality Risk Management methods implementation of design space and change management [see ICH Q10].

ICH offers to submit further questions. If you would like to submit questions or comments to be discussed at the following plenary session of the Quality IWG, please send an E-Mail to q8-9-10@ich.org

Conference tip: The ECA, the European Qualified Person Association and the University of Heidelberg are organising their biennial GMP Conference on June 23 and 24 in Heidelberg for the 3rd time. This unique event is designed as an informal and interactive forum. In 5 sessions participants are invited to discuss the latest GMP developments with major stakeholders.

Oliver Schmidt
On behalf of the European Compliance Acadamy


Conference Recommendations

Go back

GMP Conferences by Topics