Q10 Pharmaceutical Quality System
The ICH Harmonised Guideline was finalized under Step 4 in June 2008.
This Guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage.
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Date of Step 4: 4 June 2008
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
Q8/9/10 Q&As (R4) Q8/Q9/Q10 - Implementation
Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification. The Questions and Answers developed by the Quality Implementation Working Group (IWG) are intended to facilitate the implementation of the Q8(R2), Q9 and Q10 Guidelines, by clarifying key issues.
The document with the first set of Q&As was finalized under Step 4 in April 2009. Since then, new sets of questions were added three times, with the most recent version (Q8/Q9/Q10 Q&As (R4)) approved by the Steering Committee in November 2010. The ICH Quality IWG also prepared “Points to Consider” covering topics relevant to the implementation of Q8(R2), Q9 and Q10, which supplement the existing Questions & Answers and workshop training materials already produced by this group.
The document with the first and second set of Points to Consider was finalized in June and November 2011, respectively.
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Date of Step 4: 11 November 2010
Status: Step 5
Questions & Answers (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Questions & Answers
Other Documents (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Points to Consider
Endorsed Documents (Click the links below for complete guidelines)
Q8/Q9/Q10 Q&As (R4) Concept Paper
*These Guidelines Belongs to ICH website.
