Q8(R2): Pharmaceutical Development

Regulatory Resource: Q8(R2): Pharmaceutical Development

Description:

The core tripartite harmonised ICH guideline was finalised (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.
Q8 Final Concept Paper, September 2003

The annex tripartite harmonised ICH text (previously named Annex to Q8) was finalised (Step 4) in November 2008.
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 annex has been incorporated into the core guideline in November 2008.

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