ICH Q8 Pharmaceutical Development Guidelines

Q8 Pharmaceutical Development

The core ICH Harmonised Guideline was finalized under Step 4 in November 2005.

This Guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in this guideline are important to consider during these stages. This guideline might also be appropriate for other types of products. To determine the applicability of this guideline for a particular type of product, applicants should consult with the appropriate regulatory authorities.

The annex to the Harmonised ICH text was finalized under Step 4 in November 2008 and incorporated into the core Guideline, which was then renamed Q8(R1). The annex provides further clarification of key concepts outlined in the core Guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches (see Q10: Pharmaceutical Quality System).

The Q8(R1) Guideline was revised in August 2009 to reflect minor corrections to Example 2 on page 23 (Q8(R2)).
Date of Step 4: 1 August 2009
Status: Step 5

Guidelines (Click the links below for complete guidelines)

Endorsed Documents (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.
Date of Step 4: 11 November 2010
Status: Step 5

Questions & Answers (Click the links below for complete guidelines)

Other Documents (Click the links below for complete guidelines)

Endorsed Documents (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

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